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 System, 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

This document is a 510(k) premarket notification for a medical device, specifically a Diode Laser Hair Removal System. It does not describe a study involving acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) but rather focuses on verifying that the proposed device meets design specifications and is substantially equivalent to a predicate device.

Therefore, many of the requested categories (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of submission. This document details engineering and safety compliance rather than a clinical performance study.

Here's a breakdown of the available information based on your request:

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

The document does not present acceptance criteria in terms of clinical performance metrics for diagnosis (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by compliance with various international standards for medical electrical equipment, laser safety, and biocompatibility, as well as comparison to a predicate device's technical specifications. The "reported device performance" is essentially that the device complies with these standards and its technical specifications are comparable to the predicate.

Acceptance Criterion (Implied)	Reported Device Compliance/Performance
Safety and Performance Standards
IEC 60601-1:2012	Complies (Medical Electrical Equipment - General Requirements For Basic Safety And Essential Performance)
IEC 60601-2-22:2007	Complies (Medical Electrical Equipment - Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment)
IEC 60825-1:2007	Complies (Safety of laser products - Equipment classification and requirements)
IEC 60601-1-2:2007	Complies (Medical electrical equipment- Electromagnetic compatibility)
Biocompatibility
ISO 10993-5:2009 (Cytotoxicity)	No Cytotoxicity
ISO 10993-10:2002/Amd. 1:2006 (Sensitization)	No evidence of sensitization
ISO 10993-10:2002/Amd. 1:2006 (Irritation)	No evidence of irritation
Technical Specifications (Comparison to Predicate)
Product Code	GEX (Substantially Equivalent - SE)
Regulation Number	21 CFR 878.4810 (SE)
Intended Use	Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair number at 6, 9, and 12 months post-treatment. (SE to predicate K141973, comparable to K123483)
Configuration	Main Unit, Handpiece, Foot Control (SE)
Principle of Operation	Diode Laser (SE)
Laser Type	Diode Laser (SE)
Laser Classification	Class IV (SE)
Laser Wavelength	808 nm (SE)
Spot Size	1.44 cm² (SE to K141973, different from K123483's 1.2 cm², but deemed SE for overall comparison)
Fluence	1-120 J/cm² (SE)
Irradiance	0.7-347.8 W/cm² (SE to K141973, different from K123483's 600 W/cm², but deemed SE for overall comparison)
Frequency	0.5-15Hz (Discussed difference from predicates, but deemed SE for overall comparison)
Pulse Duration	5-400ms (Discussed difference from predicates, but deemed SE for overall comparison)
Power Supply	AC 110V/60Hz (SE)
Dimension	450mm×550mm×380mm (Discussed difference from predicates, but deemed SE for overall comparison)
Weight	52 kg (Discussed difference from predicates, but deemed SE for overall comparison)

2. Sample size used for the test set and the data provenance

Not Applicable: No clinical test set data is presented in this 510(k) submission for the proposed device's performance. The review relies on non-clinical testing for compliance with standards and a comparison of technical specifications to predicate devices. The section explicitly states "No clinical study is included in this submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No clinical test set and thus no ground truth established by experts is mentioned in this submission.

4. Adjudication method for the test set

Not Applicable: No clinical test set requiring adjudication is mentioned.

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 tool for "human readers." Therefore, an MRMC comparative effectiveness study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: This is a physical medical device (laser system), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable: For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence fundamentally relies on:
- Compliance with recognized industry standards (e.g., IEC, ISO) through non-clinical testing.
- Comparison of technical specifications and intended use to legally marketed predicate devices.
- The "permanent hair reduction" definition references long-term stable reduction measured at 6, 9, and 12 months after treatment, but this is an indication for use definition and not performance data from the current submission.

8. The sample size for the training set

Not Applicable: No training set data for an algorithm is relevant to this device submission.

9. How the ground truth for the training set was established

Not Applicable: No training set data for an algorithm is relevant to this device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2017

Shandong Huamei Technology Co.,ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd. Liyuan Town, Tongzhou District, Beijing Beijing, 101121 CN

Re: K162659

Trade/Device Name: Diode Laser Hair Removal System 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: October 13, 2016 Received: October 17, 2016

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. Isting 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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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)

K162659

Device Name

Diode Laser System

Indications for Use (Describe)

The Diode Laser System 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.

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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

PSC Publishing Services (301) 443-6740

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Tab #5 510(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: K162659

1. Date of Preparation
  05/19/2017
Sponsor 2.

Shandong Huamei Technology Co., Ltd.

588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261000

Establishment Registration Number: Not yet registered or the Number Contact Person: Xu QingHua Position: General Manager Tel: 86-536-2110001 Fax: 86-536-2109823 Email: xuqh@yeah.net

Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: +86-10-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: Diode Laser Hair Removal System Common Name: Powered Laser Surgical Instrument Model(s): HM-DL100

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 System 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 System, 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
  Predicate 1# 510(k) Number: K141973 Product Name: Diode Laser Hair Removal System Manufacturer: Beijing Anchorfree Technology Co., Ltd

Predicate 2# 510(k) Number: K123483 Product Name: Diode Laser Manufacturer: Beijing Syntech Laser Co., Ltd

1. 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 60601-2-2:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
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	Predicate Device	Remark
		K141973	K123483
Product Code	GEX	GEX	GEX	SE
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	SE
Intended Use	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 when measuredat 6, 9, and 12 months after thecompletion of a treatmentregime.	The Diode Laser Hair RemovalSystem 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 when measuredat 6, 9, and 12 months after thecompletion of a treatmentregime.	The Diode Laser is intendedfor use in dermatologic andgeneral surgical procedures.The Standard Mode isintended for hair removal,permanent hair reduction.The FHR Mode is intendedfor hair removal, permanenthair reduction.The diode laser system isintended for use on all skintypes (Fitzpatrick skin typesI-VI), including tanned skin.	SE
Configuration	Main Unit	Main Unit	Main Unit	SE
	Handpiece	Handpiece	Handpiece	SE
	Foot Control	Foot Control	Foot Control	SE
Principle ofOperation	Diode Laser	Diode Laser	Diode Laser	SE

Table 1 General Comparison

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Item	Proposed Device	Predicate Device	Predicate Device	Remark
		K141973	K123483
Laser Type	Diode Laser	Diode Laser	Diode Laser	SE
Laser Classification	Class IV	Class IV	Class IV	SE
Laser Wavelength	808 nm	808 nm	808 nm	SE
Spot Size	1.44 cm2	1.44 cm2	1.2 cm2	SE
Fluence	1-120J/ cm2	1-120 J/cm2	1-120 J/cm2	SE
Irradiance	0.7-347.8 W/cm2	347.2 W/cm2	600 W/cm2	SE
Frequency	0.5-15Hz	1Hz, 2Hz, 3Hz, 10Hz	≤10 Hz	Discussion
Pulse Duration	5-400ms	2.9-348ms	5-200 ms	Discussion
Power Supply	AC 110V/60Hz	AC220V, 50Hz/ AC110V,60Hz	100-240 V 50/60Hz	SE
Dimension	450mm× 550mm×380mm	380mm×540mm×1200mm	460X 365 X350 mm	Discussion
Weight	52	55kg	25 kg	Discussion

Table 2 Performance Comparison

Discussion

The proposed device is different in 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
		K141973, K123483
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Sapphire in handpiece	Sapphire in handpiece	SE
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993-1
Sensitization	No evidence of sensitization		SE
Irritation	No evidence of irritation		SE
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 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.