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.

Device Description

The diode laser system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.

The proposed system provides two working modes, which are standard hair removal mode (HR) and fast hair removal mode (FHR). They are different in the combination of frequency and fluence. Compared with HR mode, the FHR Mode (Fast Hair Removal) has low fluence and high repetition rate (10Hz).

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, including Axillary, Chest, Arm, Back, Leg, Hairline, Cheek, Lip, Beard, and Bikini;

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Diode Laser Hair Removal System L808. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria and a study to prove performance.

Therefore, many of the requested items (e.g., acceptance criteria, detailed study design, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or available in this document. The submission explicitly states: "No clinical study is included in this submission."

However, I can extract information related to the non-clinical tests and the comparison to the predicate device, which serves as the basis for the substantial equivalence determination.

Here's a breakdown of the available information:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., percentage of hair reduction, safety outcomes) for the proposed device's approval in this 510(k) summary because no clinical study was conducted. Instead, the "acceptance criteria" are implied by meeting various international safety and performance standards and demonstrating technological similarity to the predicate device.

Criterion Type	Acceptance Criteria (Implied by Standards & Predicate Comparision)	Reported Device Performance (as demonstrated by non-clinical tests and comparison to predicate)
Electrical Safety	Compliance with IEC 60601-1:2005 (General Requirements for Basic Safety and Essential Performance) and IEC 60601-2-22:2007 (Specific Requirements for Surgical Laser Equipment).	"The test results demonstrated that the proposed device complies with... IEC 60601-1:2005" and "...IEC 60601-2-22:2007."
Laser Safety	Compliance with IEC 60825-1: 2007 (Safety of laser products - Part 1: Equipment classification and requirements).	"The test results demonstrated that the proposed device complies with... IEC 60825-1: 2007."
Electromagnetic Compatibility	Compliance with IEC 60601-1-2:2007 (General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests).	"The test results demonstrated that the proposed device complies with... IEC 60601-1-2:2007."
Biocompatibility	Compliance with ISO 10993-5:2009 (Tests for Vitro cytotoxicity) and ISO 10993-10:2002/Amd. 1: 2006 (Test for irritation and delay-type hypersensitivity).	"The test results demonstrated that the proposed device complies with... ISO 10993-5:2009" and "...ISO 10993-10:2002/Amd. 1: 2006."
Technological Characteristics	Specifications (e.g., laser type, wavelength, power, modes, fluence, frequency, pulse duration) should be substantially equivalent to the predicate device. The intended use must also be substantially equivalent.	The comparison table (Table 1) shows that the proposed device has the same product code, regulation number, intended use (with slightly more detailed definition of permanent hair reduction), configuration, treatment modes, principle of operation, laser type, laser classification, laser wavelength, fluence ranges (HR mode matching, FHR mode proposed up to 25 J/cm² vs predicate ≤ 10 J/cm²), and frequency (HR mode matches, FHR mode 10Hz matching). Spot size is 1.44 cm² vs 1.2 cm² for predicate.

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

Not Applicable. No clinical study (test set) was conducted or presented in this 510(k) submission. Non-clinical tests listed are primarily engineering and bench testing, not human subject data.

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)

Not Applicable. No clinical test set requiring expert ground truth was established within this submission.

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

Not Applicable. No clinical test set requiring adjudication was established within this submission.

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-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device.

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

Not Applicable. This is a hardware device (laser system), not an algorithm. Therefore, standalone algorithm-only performance is not applicable.

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

Not Applicable for clinical performance. For the non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the referenced IEC and ISO standards. For the substantial equivalence comparison, the "ground truth" is the established technological characteristics and intended use of the legally marketed predicate device.

8. The sample size for the training set

Not Applicable. No training set for an algorithm was used as no AI/software algorithm for clinical interpretation is part of this device submission.

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

Not Applicable. As no training set was used, no ground truth for it was established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

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

October 6, 2014

Beijing Anchorfree Technology Company Ltd. % Ms. Diana Hong Shanghai Midlink Consulting Company Ltd. P.O. Box 237-023 Shanghai, China 200030

Re: K141973

Trade/Device Name: Diode Laser Hair Removal System L808 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: July 8, 2014 Received: July 21, 2014

Dear Ms. Hong:

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 801); medical device reporting (reporting of medical

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device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

Binita S. Ashar -S 2014.10.06 08:51:20 -04'00'

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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Tab #6 Indication for Use Statement

510(k) Number: Device Name: Diode Laser Hair Removal System L808

Indications for 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.

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) □OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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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: __

Date of Preparation 1.
06/30/2014
Sponsor 2.

Beijing Anchorfree Technology Co., Ltd.

1st Floor, No.1 Factory, Lightline Industrial Garden, Beijing Industrial Base of Optical, Mechanical and Electronic Integration,101111 Beijing, P.R.China

Establishment Registration Number: Not yet registered

Contact Person: Zhan, Xinying Tel: +86-10-81504710 Fax: +86-10-81502271 Email: guanzhoukeji@163.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Tarzan Wang

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Diode Laser Hair Removal System; Common Name: Laser System; Model(s): L808;

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.

Device Description 5.

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1. Identification of Predicate Device
  510(k) Number: K123483 Product Name: Diode Laser Manufacturer: Beijing Syntech Laser Co., Ltd

Intended Use:

The Diode Laser is intended for use in dermatologic and general surgical procedures.

The Standard Mode is intended for hair removal, permanent hair reduction. The FHR Mode is intended for hair removal, permanent hair reduction.

The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

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 60601-1:2005 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
1. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device
Product Code	GEX	GEX
Regulation Number	21 CFR 878.4810	21 CFR 878.4810
Intended Use	The Diode Laser Hair Removal Systemis intended for hair removal, permanenthair reduction on all skin types(Fitzpatrick skin type I-VI), includingtanned skin.Permanent hair reduction is defined asthe long-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 months afterthe completion of a treatment regime.	The Diode Laser is intended for use indermatologic and general surgical procedures.The Standard Mode is intended for hairremoval, permanent hair reduction.The FHR Mode is intended for hair removal,permanent hair reduction.The diode laser system is intended for use onall skin types (Fitzpatrick skin types I-VI),including tanned skin.
Configuration	Main UnitHandpieceFoot Control	Main UnitHandpieceFoot Control
Treatment Mode	HRFHR	HRFHR
Principle of Operation	Diode Laser	Diode Laser
Item	Proposed Device	Predicate Device
Laser Type	Diode Laser	Diode Laser
Laser Classification	Class IV	Class IV
Laser Wavelength	808 nm	808 nm
Spot Size	1.44 cm2	1.2 cm2
HR Mode
Fluence	1-120 J/cm²	1-120 J/cm²
Frequency	1Hz, 2Hz, 3Hz	≤3 Hz
Pulse Duration	2.9-348ms	5-200 ms
FHR Mode
Fluence	1-25J/cm²	≤ 10 J/cm²
Frequency	10Hz	10Hz
System Specifications
Power Supply	AC220V, 50Hz/ AC110V, 60Hz	100-240 V 50/60Hz
Dimension	380mm×540mm×1200mm	460X 365 X350 mm
Weight	55kg	25kg

Table 1 Comparison of Technology Characteristics

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

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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.