The Diode Laser Hair Removal device is intended for 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.

Device Description

The proposed device, Diode Laser Hair Removal device, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

Function module description
a. Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.
b. Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.
c. Constant current board module
The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.
d. Temperature and humidity control system
The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.
e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.

AI/ML Overview

The provided document is a 510(k) summary for a Diode Laser Hair Removal device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered device. This summary is focused on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating the performance of a novel AI/ML-based device.

Specifically, the document states: "No clinical study is included in this submission." This means there is no study described that would involve test sets, ground truth, expert adjudication, or MRMC studies that are typically associated with evaluating AI-powered devices.

However, I can extract the information provided about the device's performance based on non-clinical testing for substantial equivalence:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for a novel AI device's performance. Instead, it presents a comparison to a predicate device to demonstrate "substantial equivalence." The "acceptance criteria" here are implicitly that the proposed device performs comparably or within acceptable deviations from the predicate device based on non-clinical tests and safety standards.

Item	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed Device)	Remark
Product Code	GEX	GEX	SE (Substantially Equivalent)
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	SE
Intended Use	Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in number of hairs regrowing when measured at 6, 9, and 12 months after a treatment regime.	Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in number of hairs regrowing when measured at 6, 9, and 12 months after a treatment regime.	SE
Configuration	Main Unit, Handpiece, Foot Control	Main Unit, Handpiece, Foot Control	SE
Principle of Operation	Diode Laser	Diode Laser	SE
Laser Type	Diode Laser	Diode Laser	SE
Laser Classification	Class IV	Class IV	SE
Laser Wavelength	808 nm	808 nm	SE
Spot Size	1.44 cm2	1.44 cm2	SE
Fluence	1-120 J/cm2	1-100 J/cm2	Discussion (Difference noted, but considered SE based on non-clinical tests)
Irradiance	347.8 W/cm2	14-360 W/cm2	Discussion (Difference noted, but considered SE based on non-clinical tests)
Frequency	0.5-15 Hz	1-20 Hz	Discussion (Difference noted, but considered SE based on non-clinical tests)
Pulse Duration	5-400 ms	10-400 ms	Discussion (Difference noted, but considered SE based on non-clinical tests)
Power Supply	AC 110V/60Hz	AC 110V-230V/50-60Hz 2000VA	SE
Dimension	450mm× 550mm×380mm	560mmx380mmx1180mm	Discussion (Difference noted, but considered SE based on non-clinical tests)
Weight	52 Kg	60 Kg	Discussion (Difference noted, but considered SE based on non-clinical tests)
Patient Contact Materials and Biocompatibility	No Cytotoxicity, No evidence of sensitization, No evidence of irritation	No Cytotoxicity, No evidence of sensitization, No evidence of irritation	SE
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22	Comply with IEC 60601-1, IEC 60601-2-22	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE
Laser Safety	Comply with IEC 60601-2-22, IEC 60825	Comply with IEC 60601-2-22, IEC 60825	SE

2. Sample size used for the test set and the data provenance:
Not applicable. The document states "No clinical study is included in this submission." The testing described is non-clinical performance and safety testing directly on the device components or system, not on patient data or clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. See point 2.

4. Adjudication method for the test set:
Not applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a laser hair removal system, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. Its performance is evaluated through non-clinical testing against established safety and performance standards relevant to a laser surgical instrument, and by comparison to a predicate device.

7. The type of ground truth used:
For non-clinical tests, the "ground truth" would be the established engineering specifications for the device and compliance with recognized international standards (e.g., IEC standards for electrical, laser, and EMC safety, ISO standards for biocompatibility). For performance aspects like spot size and energy output accuracy, the ground truth is derived from validated measurement techniques.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no training set mentioned.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 17, 2018

Zhengzhou PZ Laser Slim Technology Co., Ltd Mr. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 CN

Re: K180353

Trade/Device Name: Diode laser hair removal device 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: February 6, 2018 Received: February 8, 2018

Dear Ray Wang:

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 (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. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180353

Device Name Diode laser hair removal device

Indications for Use (Describe)

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)

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Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K180353

1. Date of Preparation
  04/13/2018
1. Sponsor

Zhengzhou PZ Laser Slim Technology Co., Ltd

Fl 2th, jia Tu zhi ye, intersection of Hong Song road and lian Hua road, High-tech Development Zone, 450001, Zhengzhou City, Henan Province, China

Establishment Registration Number: Not yet registered Contact Person: Zhou Hongwei Position: General Manager Tel: +86-18736013788 Fax: +86-371-55677886 Email: 565107678@qq.com

1. Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,

FangShan District, BeiJing, China 102401

Tel: +86-10-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Diode laser hair removal device Common Name: Powered Laser Surgical Instrument Model(s): PZ-806NVA

Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX ; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Intended Use:

The Diode Laser Hair Removal device 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, Diode Laser Hair Removal device, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

Function module description

a. Control Panel

The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.

b. Main Control Module

The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.

c. Constant current board module

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The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.

d. Temperature and humidity control system

The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.

e. Handpiece module

Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.

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1. Identification of Predicate Device
  510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,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:

IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22 Edition 3.1 2012-10, 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.
IEC 60601-1-2:2014 , Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
Clinical Test Conclusion 8.

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device	Remark
		K162659
Product Code	GEX	GEX	SE
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	SE
Intended Use	The Diode Laser Hair Removaldevice is intended for hairremoval, permanent hairreduction on all skin types(Fitzpatrick skin type I-VI),including tanned skin.Permanent hair reduction isdefined as the long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9, and 12months after the completion ofa treatment regime.	The Diode Laser System isintended for hair removal,permanent hair reduction on allskin types (Fitzpatrick skintype I-VI), including tannedskin.Permanent hair reduction isdefined as the long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9, and 12months after the completion ofa treatment regime.	SE
Configuration	Main Unit	Main Unit	SE
	Handpiece	Handpiece	SE
	Foot Control	Foot Control	SE
Principle ofOperation	Diode Laser	Diode Laser	SE

Table 7-1 General Comparison

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Item	Proposed Device	Predicate Device	Remark
		K162659
Laser Type	Diode Laser	Diode Laser	SE
Laser Classification	Class IV	Class IV	SE
Laser Wavelength	808 nm	808 nm	SE
Spot Size	1.44 cm2	1.44 cm2	SE
Fluence	1-100J/cm2	1-120J/cm2	Discussion
Irradiance	14-360 W/cm2	347.8 W/cm2	Discussion
Frequency	1-20 Hz	0.5-15Hz	Discussion
Pulse Duration	10-400ms	5-400ms	Discussion
Power Supply	AC 110V-230V/50-60Hz2000VA	AC 110V/60Hz	SE
Dimension	560mmx380mmx1180mm	450mm× 550mm×380mm	Discussion
Weight	60Kg	52Kg	Discussion

Table 7-2 Performance Comparison

Discussion

The proposed device is different in fluence, frequency range, pulse duration, dimension and weight from the predicate device. By complying with non-clinical test conducted, the proposed device is determined to be substantially equivalency with predicate device.

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Item	Proposed Device	Predicate Device	Remark
		K162659
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Sapphire in handpiece	Sapphire in handpiece	SE
Cytotoxicity	No Cytotoxicity	No Cytotoxicity
Sensitization	No evidence of sensitization	No evidence of sensitization	SE
Irritation	No evidence of irritation	No evidence of irritation
EMC, Electrical and Laser Safety
Electrical Safety	Comply with IEC 60601-1, IEC60601-2-22	Comply with IEC 60601-1, IEC60601-2-22	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE
Laser Safety	Comply with IEC 60601-2-22,IEC 60825	Comply with IEC 60601-2-22,IEC 60825	SE

Table 7-3 Safety Comparison

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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.