The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

Device Description

The Handheld Diode Laser for Hair Removal is an Over-The-Counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. The device is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime permanent hair reduction is defined as long term, stale reduction in the number of hairs regrowing when measured out of 6, 9, and 12 months after the completion of the treatment regimen.

The Handheld Diode Laser for Hair Removal is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 808nm.

Laser hair removal is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue.

Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Handheld Diode Laser for Hair Removal. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this submission.

Here's a breakdown of what can be extracted and what is explicitly stated as not applicable:

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

No explicit "acceptance criteria" for clinical performance are presented in the form of a table with specific thresholds. The submission's primary goal is to show equivalence to predicate devices based on technical specifications and safety standards, not to demonstrate performance against predefined clinical metrics for hair removal efficacy.

However, the safety and performance aspects are compared to established standards and predicate devices. The "Performance Comparison" table (Table 2) lists technical specifications. For safety, the device's compliance with various IEC and ISO standards is presented.

Technical Specifications Comparison (Table 2)

Item	Proposed Device Performance (Handheld Diode Laser for Hair Removal)	Predicate Device (K120737) Performance	Predicate Device (K142845) Performance	Acceptance Criteria (Implicit: Substantial Equivalence to Predicates)
Laser Type	Diode Laser	Diode Laser	Diode Laser	Match predicate devices
Laser Classification	Class IV	Class IV	Class IV	Match predicate devices
Laser Wavelength	808 nm	810 nm	810 nm	Substantially equivalent (808nm vs 810nm considered SE)
Spot Size	∅9mm (Round)	∅10mm (Round)	9x9 mm	Considered substantially equivalent (see "Discussion 1")
Fluence	5.5 - 21.2 J/cm²	7-22 J/cm²	5 - 25 J/cm²	Considered substantially equivalent (overlapping ranges, see "Discussion 2")
Power Supply	AC 110V/50Hz-60Hz	100-240 V 50/60Hz	100-240 V 50/60Hz	Substantially equivalent

Safety and Biocompatibility (Table 3)

Item	Proposed Device Performance	Acceptance Criteria (Compliance with Standards/PredicateEquivalence)
Patient Contact Materials and Biocompatibility	Sapphire in handpiece and handpiece tip (Stainless Steel)	Match predicate devices (Stainless steel and Sapphire in handpiece)
Cytotoxicity	No Cytotoxicity (Comply with ISO 10993-5)	Comply with ISO 10993-1
Sensitization	No evidence of sensitization (Comply with ISO 10993-10)	Comply with ISO 10993-10
Irritation	No evidence of irritation (Comply with ISO 10993-10)	Comply with ISO 10993-10
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22	Comply with IEC 60601-1, IEC 60601-2-22
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Laser Safety	Comply with IEC 60601-2-22, IEC 60825	Comply with IEC 60601-2-22, IEC 60825

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set (Usability Study):
- Group 1: 13 participants (7 females, 6 males; ages 19-71 years). Included two participants with dark skin tone and one with blond hair.
- Group 2: 10 participants (5 females, 5 males; ages 19-73 years).
Data Provenance: Not explicitly stated, but given the sponsor and correspondent's addresses (China), it's highly probable the study was conducted in China. The study appears to be prospective, observing participants as they interacted with the device and its labeling.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Ground Truth for Clinical Efficacy: Not applicable, as no clinical study was performed, and thus no clinical ground truth was established for the test set in this context.
Ground Truth for Usability Study: The "tester" observed user interactions, recorded questions, and answered them. The qualifications of this "tester" are not provided. The ground truth here was observational data on user comprehension and ability to operate the device based on labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable for clinical performance. For the usability study, there isn't a formal adjudication method described. The "tester" collected observations, and the instructional manual was revised based on user feedback. A second group was then tested to confirm improvements.

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

MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is a hair removal laser, not an diagnostic AI system involving human readers.

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

Standalone Performance Study: No, a standalone performance study in the context of clinical efficacy (e.g., hair reduction rates) was explicitly not done. The document states: "No clinical study is included in this submission."
However, "non-clinical tests" were conducted to verify compliance with design specifications and safety standards (e.g., IEC, ISO, electrical safety, EMC, laser safety, biological evaluation). These tests are standalone in the sense that they evaluate the device's adherence to technical requirements without human clinical involvement.

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

For Clinical Efficacy: Not applicable, as no clinical study was performed.
For Usability Study: The ground truth for the usability study was the direct observation of user comprehension and their ability to properly use and clean the device based on the provided labeling (Instruction Manual Rev: V 1.02 and V 1.03). User questions and difficulties were the primary "data" for identifying areas for improvement.

8. The sample size for the training set

Training Set (for Device Development/Optimization): Not explicitly stated. The document describes usability testing and "non clinical tests" but does not detail a "training set" in the context of machine learning or extensive data-driven model development. The development process likely involved engineering iterations rather than a formal training set as understood in AI/ML.

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

Ground Truth for Training Set: Not applicable as a formal "training set" with established ground truth for clinical performance or an AI model is not described in this submission. The development and verification process relied on compliance with engineering standards and usability feedback, rather than a clinical training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

February 8, 2017

Liaoning Sidey Optoelectronics Technologies Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd., Liyuan Town, Tongzhou Beijing, 101121 CN

Re: K163173

Trade/Device Name: Handheld Diode Laser For Hair Removal 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: OHT Dated: November 7, 2016 Received: November 14, 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, 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

{1}------------------------------------------------

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 -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163173

Device Name Handheld Diode Laser for Hair Removal

Indications for Use (Describe)

The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permant hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

Type of Use (Select one or both, as applicable)	Research involving HHS conducted or supported research Clinical Trial, Cooperative Agreement, HHS conducted or supported research	Research involving HHS conducted or supported research	Clinical Trial, Cooperative Agreement, HHS conducted or supported research
Research involving HHS conducted or supported research
Clinical Trial, Cooperative Agreement, HHS conducted or supported research

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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 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."

{3}------------------------------------------------

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: __K163173

1. Date of Preparation
  11/07/2016
Sponsor 2.

Liaoning Sidey Optoelectronics Technologies Co., Ltd.

No.6 Building,No.262 Yueling Rd,high-tech industrial development zone,114044,Anshan,Liaoning,China Establishment Registration Number: Not yet registered or the Number Contact Person: Li Zhao Position: Registration Manager Tel: +86-10-56370050 Fax: +86-10-56370076 Email: small@honkonlaser.com

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

{4}------------------------------------------------

1. Identification of Proposed Device
  Trade Name: Handheld Diode Laser for Hair Removal Common Name: Light Based Over-The-Counter Hair Removal Model(s): SD-BD01

Regulatory Information:

Classification Name: Light Based Over-The-Counter Hair Removal Classification: II; Product Code: OHT; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Intended Use Statement:

న్. Device Description

The Handheld Diode Laser for Hair Removal is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 808nm.

{5}------------------------------------------------

1. Identification of Predicate Device
  Predicate 1#: 510(k) Number: K120737 Product Name: TRIA Laser Hair Removal System Manufacturer: Tria Beauty, Inc.

Predicate 2#: 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Company, 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 60601-2-22:2007, Medical Electrical Equipment Part 2-22: Particular Requirements For Basic > Safety And Essential Performance Of Surgical, Cosmetic And Diagnostic Laser Equipment;
IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification and requirements. A
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.
IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for medical device equipment and medical electrical systems used in the home healthcare environment.
A 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.

A Usability/Label Comprehension Study was conducted.

Two smaller groups out of these participants were chosen to participate in a usability study in which the actual product along with its labeling would be tested.

The first group of 13 participants consisted of 7 females, 6 males and their ages ranged from 19-71 years. Two participants with dark skin tone and one participant with blond hair were included in this group. It was explained to them what the study was all about and then were asked (two at a time) to pretend that they had just purchased the product and were to use it for the first.

{6}------------------------------------------------

The tester allowed ample time for the users to read/study the labeling, include information on retail box, name plate and Instruction Manual Rev: V 1.02, completely while recording questions and answering them. Then the actual use of the product was observed, remarks and questions were recorded.

Then we revised the Instruction Manual form Rev: V 1.03 according with the question from the tester.

A second group of 10 participants was chosen for a second test. There were 5 females, 5 males and their ages ranged between 19 and 73 years.

Again, after allowing ample time to read and study the Instruction Manual Rev: V 1.03, the questions asked came down to only 2 and they were not pertaining to safety or operation.

Results

For the first groups,

1. All participants understood the "Skin Tone Chart", Warnings, Indications and Contraindications;
1. Three user refused to use the product after reading the determination as "Skin Tone Chart" and
Indications, because skin tone and hair color;
1. 9 of the remaining 10 users had questions.

The inputs of the first groups needed some changes and additions to the Instruction Manual (Rev: V 1.02). For the second groups, the result showed that all (100%) participants were able to properly use the device and properly clean it with the labeling submitted.

The inputs of the second test groups did not warrant any more changes and additions to the Instruction Manual (Rev: V 1.03).

1. Clinical Test Conclusion
  No clinical study is included in this submission.

{7}------------------------------------------------

9. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device	Predicate Device	Remark
		K120737	K142845
Product Code	OHT	GEX	OHT	SE
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	SE
Intended Use	The Handheld Diode Laser for HairRemoval is an over-the-counterdevice intended for adjunctive usewith shaving for hair removalsustained with periodic treatments.Handheld Diode Laser for HairRemoval is also intended forpermanent reduction in hairregrowth defined as a long-term,stable reduction in hair countsfollowing a treatment regime.permanent hair reduction is definedas long term, stable reduction in thenumber of hairs regrowing whenmeasured out to 6, 9, and 12months after the completion of thetreatment regimen.	The TRIA is anover-the-counter deviceintended for adjunctive usewith shaving for hair removalsustained with periodictreatments. TRIA is alsointended for permanentreduction in hair regrowthdefined as a long-term, stablereduction in hair countsfollowing a treatment regime.permanent hair reduction isdefined as long term, stablereduction in the number ofhairs regrowing whenmeasured out to 6, 9, and 12months after the completion ofthe treatment regimen.	The SILKPRO is anover-the-counter deviceintended for adjunctive usewith shaving for hair removalsustained with periodictreatments. SILKPRO is alsointended for permanentreduction in hair regrowthdefined as a long-term, stablereduction in hair countsfollowing a treatment regime.permanent hair reduction isdefined as long term, stablereduction in the number ofhairs regrowing whenmeasured out to 6, 9, and 12months after the completion ofthe treatment regimen.	SE
Prescription/OTC	OTC	OTC	OTC	SE
Principle ofOperation	Diode Laser	Diode Laser	Diode Laser	SE

Table 1 General Comparison

{8}------------------------------------------------

Item	Proposed Device	Predicate Device	Predicate Device	Remark
		K120737	K142845
Laser Type	Diode Laser	Diode Laser	Diode Laser	SE
Laser Classification	Class IV	Class IV	Class IV	SE
Laser Wavelength	808 nm	810 nm	810 nm	SE
Spot Size	∅9mm (Round)	∅10mm (Round)	9x9 mm	Discussion 1
Fluence	5.5 - 21.2 J/cm²5.5 J/cm², 11 J/cm², 16.5 J/cm², 21.2 J/cm²	7-22 J/cm²6 J/cm², 10 J/cm², 14 J/cm², 18 J/cm², 22 J/cm²	5 - 25 J/cm²5 J/cm², 10 J/cm², 15 J/cm², 20 J/cm², 25 J/cm²	SEDiscussion 2
Power Supply	AC 110V/50Hz-60Hz	100-240 V 50/60Hz	100-240 V 50/60Hz	SE

Table 2 Performance Comparison

Discussion 1

The proposed device is different in Spot Size from the proposed devices' pulse duration range is cover the predicates' and both proposed device and predicate has same Fluence, this difference will not affect the substantially equivalency.

Discussion 2

The proposed device is different in fluence setting level from the proposed devices' pulse duration range is cover the predicates' and both proposed device and predicate has same Fluence, this difference will not affect the substantially equivalency.

{9}------------------------------------------------

Item	Proposed Device	Predicate Device	Remark
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Sapphire in handpiece and handpiece tip(Stainless Steel)	Stainless steel and Sapphire in handpiece	SE
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993-1
Sensitization	No evidence of sensitization		SE
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 3 Safety Comparison

1. 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.