July 25, 2025

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Xiaojie Shi
RA
Room 201, 2nd Floor, Building 2, No.52 Hongsong Road
High-tech Development Zone, 450001
China

Re: K251339
Trade/Device Name: Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-
BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In
Dermatology
Regulatory Class: Class II
Product Code: GEX
Dated: April 21, 2025
Received: April 30, 2025

Dear Xiaojie Shi:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above
and have determined the device is substantially equivalent (for the indications for use stated in the enclosure)
to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the
provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general controls
provisions of the Act. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.08.00
Silver Spring, MD 20993
www.fda.gov
K251339 - Xiaojie Shi Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent
parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule").
The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label
and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the
dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR
830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device
Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these
requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-
comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).
K251339 - Xiaojie Shi Page 3

Sincerely,

YAN FU -S
Digitally signed by YAN FU -S
Date: 2025.07.25 12:10:49
-04'00'

for Tanisha Hithe

Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 07/31/2026
Indications for Use See PRA Statement below.

510(k) Number (if known)

K251399

Device Name
Medical Diode Laser Hair Removal Device (PZ-606ⅥPZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

Indications for Use (Describe)

The Medical Diode Laser Hair Removal Device (PZ-606ⅥPZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at
6, 9, and 12 months after the completion of a treatment regime.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
The assigned 510(k) Number: K251399

510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in

accordance with requirements of SMDA 1990 and 21 CFR 807.92.

1. Date of preparation: 07/24/2025

2. Sponsor Identification:

Zheng zhou PZ Laser Slim Technology Co., Ltd.

Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone,

450001, Zhengzhou City, Henan Province, P. R. China.

Contact Person: Xiaojie Shi

Position: RA

Tel:+86-18703657355

Fax:+86-0371-55677886

Email: [email protected]

3. Designated Submission Correspondent

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone,

450001, Zhengzhou City, Henan Province, P. R .China.

Contact Person: Xiaojie Shi

Tel:+86-18703657355

Fax:+86-0371-55677886

Email: [email protected]

4. Identification of Proposed Device

Trade Name: Medical Diode Laser Hair Removal Device

Models: PZ-606Ⅵ、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04

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Common Name: Powered Laser Surgical Instrument

Regulatory Information

Classification Name: Powered Laser Surgical Instrument

Classification: II

Product Code: GEX

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in
dermatology.
Review Panel: General& Plastic Surgery

Intended Use:

The Medical Diode Laser Hair Removal Device (PZ-606Ⅵ、PZ-BDT68-01、PZ-BDT68-02、

PZ-BDT68-03、PZ-BDT68-04) is intended for hair removal, permanent hair reduction on all

skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs

regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

5. Device Description:

The proposed device, Medical Diode Laser Hair Removal Device (PZ-606Ⅵ、PZ-BDT68-01、

PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair

removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a

wavelength of 808 nm. According to the selective light absorption theory, the laser can be

preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of

permanent hair removal. Permanent hair reduction is defined as the long-term, stable

reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the

completion of a treatment regime. Hair growth must remain stable for a certain amount of

time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal

does not mean that all hair in the treated area is completely lost. Special cooling technology is

applied simultaneously during treatment to cool the skin and protect skin.

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There are 5 models included, PZ-606Ⅵ, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and

PZ-BDT68-04, the five models have the same intended use, mechanism of action and

principle, only the minimum values of energy density and pulse duration are different. The

detailed difference shown as following:

Table 1 The difference of Models

Pulse width
Energy density
Model Wavelength Laser emitter （Pulse duration)
(±20%)
(±10%)
1000W 12*12
3-108ms (2-50) J/cm2
808nm±10nm laser treatment head
(Handle 1) 1000W Φ6mm treatment
4-44ms (3-30) J/cm2
head
2000W 12*12
PZ-606VI 3-80ms (3-95) J/cm2
laser treatment head
808nm±10nm 2000W 12*24
3-80ms (2-55) J/cm2
(Handle 2) laser treatment head
2000W Φ6mm treatment
3-22ms (3-30) J/cm2
head
1000W 12*12
6-108ms (5-50) J/cm2
808nm±10nm laser treatment head
(Handle 1) 1000W Φ6mm treatment
7-44ms (5-30) J/cm2
head
PZ-BDT6 2000W 12*12
4-80ms (5-95) J/cm2
8-01 laser treatment head
808nm±10nm 2000W 12*24
8-80ms (5-55) J/cm2
(Handle 2) laser treatment head
2000W Φ6mm treatment
5-22ms (5-30) J/cm2
head
1000W 12*12
12-108ms (10-50) J/cm2
808nm±10nm laser treatment head
(Handle 1) 1000W Φ6mm treatment
15-44ms (10-30) J/cm2
head
PZ-BDT6 2000W 12*12
9-80ms (10-95) J/cm2
8-02 laser treatment head
808nm±10nm 2000W 12*24
15-80ms (10-55) J/cm2
(Handle 2) laser treatment head
2000W Φ6mm treatment
8-22ms (10-30) J/cm2
head
1000W 12*12
PZ-BDT6 808nm±10nm 3-108ms (2-50) J/cm2
laser treatment head
8-03 (Handle 1)
1000W Φ6mm treatment 7-44ms (5-30) J/cm2

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 head
2000W 12*12
3-80ms (3-95) J/cm2
laser treatment head
808nm±10nm 2000W 12*24
3-80ms (2-55) J/cm2
(Handle 2) laser treatment head
2000W Φ6mm treatment
5-22ms (5-30) J/cm2
head
1000W 12*12
3-108ms (2-50) J/cm2
808nm±10nm laser treatment head
(Handle 1) 1000W Φ6mm treatment
15-44ms (10-30) J/cm2
head
PZ-BDT6 2000W 12*12
3-80ms (3-95) J/cm2
8-04 laser treatment head
808nm±10nm 2000W 12*24
3-80ms (2-55) J/cm2
(Handle 2) laser treatment head
2000W Φ6mm treatment
8-22ms (10-30) J/cm2
head

6. Identification of Predicate Device and reference devices

Predicate device:
510(k) Number: K161692
Product Name: Diode Laser Therapy Machine
Manufacturer: Beijing ADSS Development Co., Ltd

Reference device1:
510(k) Number: K140009
Product Name: The Modified Alma Lasers Soprano XL™ Family of Multi-Application and
Multi-Technology Platforms [SopranoXL, SopranoXLi and SopranoICE]
Manufacturer: Alma Lasers Ltd

Reference device2:
510(k) Number: K210663
Product Name: Dermatological Diode Laser Systems
Manufacturer: Beijing HuaCheng Taike Technology Co., Ltd.

Reference device3:
510(k) Number: K141973
Product Name: Diode Laser Hair Removal System L808
Manufacturer: Beijing Anchorfree Technology Company Ltd.

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design
specifications as was Substantially Equivalent (SE) to the predicate device. The test results
demonstrated that the proposed device complies with the following standards:

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IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance;
IEC 60601-1-2:2014+A1:2020, Medical electrical equipment- Part 1-2: General
requirements for basic safety and essential performance- Collateral standard:
Electromagnetic - Requirements and tests;
IEC 60601-2-22:2019, Medical electrical equipment - Part 2-22: Particular requirements
for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic
laser equipment
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and
requirements
ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in Vitro
cytotoxicity.
ISO 10993-10:2021, Biological Evaluation of Medical Devices, Part 10-Tests for skin
sensitization
ISO 10993-23:2021, Biological Evaluation of Medical Devices-Part 23: Tests for irritation.
Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

8. Clinical Test Conclusion

No clinical study is included in this submission.

9. Substantially Equivalent (SE) Comparison

Table 2 General Comparison

Item Proposed Device Predicate Device Remark
Product Code GEX GEX Same
Regulation 21 CFR 878.4810 21 CFR 878.4810 Same
Number
Intended Use The Medical Diode Laser Hair The Diode Laser Therapy Same
Removal Device is intended Machine is intended for hair
for hair removal, permanent removal, permanent hair
hair reduction on all skin types reduction on all skin types
(Fitzpatrick skin type I-VI), (Fitzpatrick skin type I-VI),
including tanned skin. including tanned skin.
Permanent hair reduction is Permanent hair reduction is
defined as the long-term, defined as the long-term,
stable reduction in the number stable reduction in the
of hairs regrowing when number of hairs regrowing
measured at 6, 9, and 12 when measured at 6, 9, and
months after the completion of 12 months after the
a treatment regime. completion of a treatment
regime.
Configuration Main Unit Main Unit Same
Handle Handpiece Same
Handle Button Foot Control Difference
1

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Principle of Diode Laser Diode Laser Same
Operation
Laser Type Diode Laser Diode Laser Same
Laser Class Ⅳ Class Ⅳ Same
Classification
Laser 808nm 808nm Same
Wavelength
Spot Size 1.44cm2 1.44cm2 Same
2.88cm2 Difference
0.28cm2 2
Energy (1)1000W 12*12 2-120J/cm2 Difference
Density treatment head: (2-50) J/cm2 3
(Fluence) (2)1000W Φ6mm treatment
head: (3-30)J/cm2
(3)2000W 12*12
treatment head: (3-95)J/cm2
(4)2000W 12*24
treatment head: (2-55)J/cm2
(5)2000W Φ6mm treatment
head: (3-30)J/cm2
Frequency (1)1-10Hz 1-10Hz Same
(2)1-3Hz
Pulse (1)1000W 12*12 9-143ms Difference
Duration laser treatment head: 3-108ms 4
(2)1000W Φ6mm treatment
head: 4-44ms
(3)2000W 12*12
laser treatment head: 3-80ms
(4)2000W 12*24
laser treatment head: 3-80ms
(5)2000W Φ6mm treatment
head: 3-22ms
Power Supply AC100-240V 50/60Hz AC 110V/50Hz-60Hz Difference
5
Dimension 550mm*550mm*1700mm 56*46*112 cm Difference
42*63*54cm 6
56*46*110cm
59*59*146 cm
Weight 68kg 49kg Difference
30kg 7
45kg
45kg
Analysis:
Difference1:

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The predicate device emits laser through Foot Control; The proposed device emits laser
through Handle Button. By complying with IEC 60601-1, the performance of the proposed
device is determined to be accepted, therefore, this difference will not affect the effectiveness
and safety.

Difference 2:
The spot size of the subject device (1.44cm2, 2.88 cm2, and 0.28 cm2) differs from predicate
device (1.44cm2).
For the small spot size (0.28 cm2), which is the same as the spot size of the 6mm round
tapered light guide tip in K140009, the round area is calculated to be 0.28 cm2, it is the same
as that of the subject device.
The large spot size (2.88 cm2) is similar to the spot size (3 cm2) of CM01D in K210663, and
the spot size of the proposed device is slightly smaller than 3 cm2.
So we think this minor difference between proposed device and predicate device will not
affect the effectiveness and safety. And the proposed device has passed the IEC60601-1 test,
IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and
performance of the product can be ensured.

Difference 3:
The proposed device has different Fluence from the predicate device. The fluence of the
proposed device is within the range of the predicate device, which can justify that the
difference in the parameter of fluence will not raise new safety issues of the proposed device.
And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22
test, IEC60825-1 test and performance test, the safety and performance of the product can be
ensured. And we think this minor difference will not affect the effectiveness and safety.

Difference 4:
The proposed device has different pulse duration from the predicate device (K161692). The
pulse duration of the predicate device is 9-143ms, and the pulse duration of the subject device
is 3-108ms. The pulse duration between the proposed device and the predicate device only
with minor difference. The K141973 (pulse duration 2.9-348ms) as a scientifically valid
justification that extending the pulse duration of the proposed device to 3-108ms is as safe
and effective as the predicate device, and the K141973 has the same indication for use with
predicate device will not affect the effectiveness and safety. And the proposed device has
passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and
performance test, the safety and performance of the product can be ensured.

Difference 5：
The power supply for the proposed device is different from the predicate device. However,
electrical safety and EMC test has been conducted on the proposed device and the test result
show that the device can work normally under this power supply. Therefore, this difference
will not affect safety and effectiveness of the proposed device.

Difference 6:

7 / 8
The proposed device is different in dimension from the predicate device. By complying with
IEC 60601-1, the mechanical performance of the proposed device is determined to be
accepted, therefore, this difference of dimension have no effect the effectiveness and safety.

Difference 7:
The proposed device is different in weight from the predicate device. By complying with IEC
60601-1, the mechanical performance of the proposed device is determined to be accepted,
therefore, this difference of weight have no effect the effectiveness and safety.

Table 3 Safety Comparison

Item Proposed Device Predicate Device Remark
Patient Contact Materials and Biocompatibility
Cytotoxicity No Cytotoxicity No Cytotoxicity Same
Sensitization No evidence of No evidence of Same
sensitization sensitization
Irritation No evidence of No evidence of Same
irritation irritation
EMC, Electrical and Laser Safety
Electrical Safety Comply with IEC Comply with IEC Same
60601-1, IEC 60601-1, IEC
60601-2-22 60601-2-22
EMC Comply with IEC Comply with IEC Same
60601-1-2 60601-1-2
Laser Safety Comply with IEC Comply with IEC Same
60601-2-22, IEC 60825 60601-2-22, IEC
60825

10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be
Substantially Equivalent (SE) to the predicate device.

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