DIODE LASER THERAPY SYSTEMS

K152898 · Beijing Sincoheren Science and Tech. Development Co., Ltd. · GEX · Feb 9, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152898
• Device Name: DIODE LASER THERAPY SYSTEMS
• Applicant: Beijing Sincoheren Science and Tech. Development Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 Therapy System (Model SDL-B) emits 808nm laser light via handpiece to target chromophores in hair follicles. System includes console, treatment handpiece, and foot switch. Operates by delivering controlled pulse duration and energy density to induce thermal damage to target tissue while utilizing water-based epidermal cooling to protect surrounding skin. Used in clinical settings by trained operators. Output parameters (fluence, pulse duration, frequency) are adjusted by the clinician to achieve hair reduction. Benefits include long-term, stable reduction of hair regrowth.

Clinical Evidence

Bench testing only. No clinical data provided. Performance supported by biocompatibility testing (cytotoxicity, sensitization, irritation per ISO 10993), electrical safety, and EMC testing.

Technological Characteristics

Diode laser system emitting 808nm wavelength. Features sapphire optical window, water cooling system, and foot switch control. Dimensions: 12mm x 10mm spot size. Electrical safety per IEC 60601-1 and IEC 60825-1; EMC per IEC 60601-1-2. Software classified as moderate level of concern.

Indications for Use

Indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI).

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

• Emvera Diolux (K123257)

Submission Summary (Full Text)

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

February 9, 2016

Beijing Sincoheren Science And Tech. Development Co., Ltd % Mr. Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technology Service Co., Ltd 7th Floor, Jingui Business Building, No.982 Congyun Rd. Baiyun District Guangzhou, 510420 CN

Re: K152898

Trade/Device Name: Diode Laser Therapy Systems 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: September 20, 2015 Received: October 1, 2015

Dear Mr. Gu:

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

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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 (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.

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/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# 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

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## Indications for Use

510(k) Number (if known) K152898

Device Name

Diode Laser Therapy Systems, Model SDL-B

### Indications for Use (Describe)

The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

#### l. SUBMITTER

Beijing Sincoheren Science and Technology Development Co., Ltd. Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044, China Phone: [phone]

Fax: [phone]

| Primary Contact Person: | Mike Gu |
|---------------------------|-------------------------------------------------------|
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Xin Wang |
| | Quality Manager |
| | Beijing Sincoheren Science and Technology Development |
| | Co., Ltd. |
| | Tel: [phone]-8002 |
| | Fax: [phone]-8007 |

II. DEVICE

| Name of Device: | Diode Laser Therapy Systems, Model SDL-B |
|-----------------|------------------------------------------|
|-----------------|------------------------------------------|

| Name of Device: | Diode Laser Therapy Systems, Model SDL-B |
|-----------------------|-----------------------------------------------------|
| Common/Usual Name: | Diode Laser Therapy Systems |
| Classification Names: | Powered Laser Surgical Instrument (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |

PREDICATE DEVICE lll.

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Image /page/4/Picture/0 description: The image is a green square with a white design on it. The design appears to be abstract, possibly representing a stylized plant or organic form. The white color contrasts sharply with the green background, making the design stand out. The overall impression is simple and modern.

## Emvera Diolux, K123257

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The Diode Laser Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.

#### V. INDICATION FOR USE

The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI).

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.

| Specification | Predicate device | Proposed device | Discussion of<br>Differences |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| K number | K123257 | -- | |
| Manufacturer | Emvera Technologies, LLC. | Beijing Sincoheren Science and<br>Technology Development Co., Ltd. | |
| Device name | Emvera Diolux | Diode Laser Therapy Systems | |
| Intended Use | The Emvera Diolux is intended for<br>hair removal, permanent hair<br>reduction on all skin<br>types (Fitzpatrick skin type I-VI).<br><br>Permanent hair reduction is<br>defined as the long-term, stable<br>reduction in the number of hairs<br>regrowing when measured at 6, 9<br>and 12 months after the<br>completion of a treatment<br>regime. | The Diode Laser Therapy Systems<br>are intended for hair removal,<br>permanent hair reduction on all skin<br>types (Fitzpatrick skin type I-VI).<br><br>Permanent hair reduction is defined<br>as the long-term, stable reduction in<br>the number of hairs regrowing when<br>measured at 6, 9 and 12 months<br>after the completion of a treatment<br>regime. | same |

#### VI. SUBSTANTIAL EQUIVELENCE

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| Specification | Predicate device | Proposed device | Discussion of Differences |
|-----------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------|
| Wavelength<br>(nm) | 808 | 808 | Same |
| Output power<br>(W) | 600 | 500 | Less than the<br>output of<br>predicate<br>device. |
| Fluence (Energy<br>Density) | <120 J/cm² | <120 J/cm² | Same |
| Pulse Duration | 5ms-625ms | 5ms-400ms | The<br>maximum<br>pulse<br>duration is<br>smaller than<br>the predicate<br>device. |
| Frequency | 1Hz-10Hz | 1Hz-10Hz | Same |
| Spot Size | 12mm × 12mm | 12mm × 10mm | Smaller than<br>the predicate<br>device. |
| Material | Sapphire | Sapphire | Same |
| Cooling | Water cooling | Water cooling | Same |
| Anatomical Sites | Axilla, Face, bikini, Upper limb<br>and lower limb, brow, upper lip,<br>neck, chest, back | Axilla, Face, bikini, Upper limb and<br>lower limb | Less than the<br>predicate<br>device. |

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for the device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The laser output window of testing included the following tests:

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Image /page/6/Picture/1 description: The image is a close-up of a logo or symbol set against a green background. The logo appears to be white and stylized, possibly representing a letter or a combination of abstract shapes. The white design contrasts sharply with the green, making it stand out. The image is cropped, focusing on the central part of the logo.

- Cytotoxicity
- Sensitization
- Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the device. The system complies with the IEC 60601-1 and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.

## Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure of latent design flaw could directly result in minor injury to the patient or operator.

#### VIII. CONCLUSION

The Diode Laser Therapy Systems and its application comply with standards as detailed in section 9, 11 and 17 of this premarket notification. Non-clinical tests determined that the Diode Laser Therapy Systems to be as safe, as effective and performance is substantially equivalent to the predicate device.