DIODE LASER HAIR REMOVAL SYSTEM

K141973 · Beijing Anchorfree Technology Co., Ltd. · GEX · Oct 6, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141973
• Device Name: DIODE LASER HAIR REMOVAL SYSTEM
• Applicant: Beijing Anchorfree Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Diode Laser Hair Removal System L808 is a surgical laser device for dermatologic procedures. It utilizes a semiconductor diode laser source emitting 808 nm infrared radiation. The system includes a main unit, a laser handpiece, and a footswitch for activation. It operates in two modes: Standard Hair Removal (HR) and Fast Hair Removal (FHR), which differ in fluence and repetition frequency (up to 10Hz in FHR). The device is intended for use by healthcare professionals in clinical settings. The laser energy is delivered to the treatment area to target hair follicles. By achieving permanent hair reduction, the device provides cosmetic benefits to patients seeking long-term hair removal across various body areas, including axillary, chest, arm, back, leg, face, and bikini regions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-22), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Semiconductor diode laser; 808 nm wavelength; Class IV laser. Two modes: HR (1-120 J/cm², 1-3Hz) and FHR (1-25 J/cm², 10Hz). Spot size 1.44 cm². Powered by AC 110V/220V. Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all Fitzpatrick skin types (I-VI), including those with tanned skin.

Regulatory Classification

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.

Predicate Devices

• Diode Laser (K123483)

Submission Summary (Full Text)

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

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

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

## 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

{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: __

- 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Tarzan Wang

## Mid-Link Consulting Co., Ltd

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

Tel: [phone], Fax: [phone] Email: [e-mail]

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

#### 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.

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;

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

- 6. 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.

- 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 60601-1:2005 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
- 8. Clinical Test Conclusion

No clinical study is included in this submission.

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

#### 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 System<br>is intended for hair removal, permanent<br>hair reduction on all skin types<br>(Fitzpatrick skin type I-VI), including<br>tanned skin.<br><br>Permanent hair reduction is defined as<br>the long-term, stable reduction in the<br>number of hairs regrowing when<br>measured at 6, 9, and 12 months after<br>the completion of a treatment regime. | The Diode Laser is intended for use in<br>dermatologic and general surgical procedures.<br><br>The Standard Mode is intended for hair<br>removal, permanent hair reduction.<br><br>The FHR Mode is intended for hair removal,<br>permanent hair reduction.<br><br>The diode laser system is intended for use on<br>all skin types (Fitzpatrick skin types I-VI),<br>including tanned skin. |
| Configuration | Main Unit<br>Handpiece<br>Foot Control | Main Unit<br>Handpiece<br>Foot Control |
| Treatment Mode | HR<br>FHR | HR<br>FHR |
| 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

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

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

Equivalent (SE) to the predicate device.