SILK'N

K072906 · Home Skinovations , Ltd. · GEX · Jan 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072906
• Device Name: SILK'N
• Applicant: Home Skinovations , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

Device Story

Silk'n is a light-based hair removal system consisting of a base unit and handheld applicator. It utilizes selective photothermal treatment to remove unwanted hair. The device is intended for patient self-use in a home or clinical setting, provided the patient has received training by a healthcare professional and operates under the direction of a physician. The system delivers light energy to target hair follicles; the resulting thermal effect inhibits hair growth. The device complies with FDA performance standards 21 CFR 1040.10 and 1040.11.

Clinical Evidence

Prospective clinical study conducted to support safety and effectiveness. Results demonstrated the system functions as intended with no adverse events reported.

Technological Characteristics

Light-based hair removal system; base unit and handheld applicator; energy source complies with 21 CFR 1040.10 and 1040.11; selective photothermal treatment principle.

Indications for Use

Indicated for patient removal of unwanted hair via selective photothermal treatment under physician direction following professional training.

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

• ABC hair removal system (K060839)
• SpaTouch Photoepilation system (K020856)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTI Home SkinovationsLtd. Silk'n

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

2008

### Submitter's information

| Name: | Home Skinovations Ltd. |
|----------|------------------------------------------------|
| Address: | Apolo building, POB 533, Yokneam 20692, Israel |
| Contact: | Dr. Amir Waldman VP Regulatory Affairs |

### Device information

| Trade/Proprietary name: | Silk'n |
|-------------------------|----------------------------------------------------------------------------------------------------------|
| Common/Usual name: | Light based hair removal device |
| Classification name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology (21CRF §878.4810) |
| Product code: | GEX |

# Predicate devices

- . ABC hair removal system, (K060839) Palomar Medical Technologies Inc.
- . SpaTouch Photoepilation system, (K020856) Radiancy Ltd.

### Intended use:

The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

# Device Description:

The Silk'n hair removal system is composed of a base unit and hand held applicator. Details are provided in the chapter 1: Device description, of this submission.

### Performance & clinical data:

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The device complies with the following U.S. Food and Drug Administration performance standards: 21CRF § 1040.10 & 1040.11. Clinical data was collected in a prospective clinical study to support the safety and effectiveness of the Silk'n hair removal device. The clinical studies demonstrated that the Silk'n system functions as intended with no adverse events.

#### Substantial Equivalence:

The Silk'n system is substantial equivalent to its predicate devices. The data in this 510k submission demonstrate that the Silk'n system shares the same intended use and similar overall characteristic, therefore is substantial equivalent to its predicate devices. Details are provided in chapter 3: Substantial equivalent of this submission.

Based upon an analysis of the overall performance characteristic for the device, Home Skinovations Ltd. believes that no significant differences exit. Therefore the Silk'n should raise no new issues of safety or effectiveness.

January 11, 2008

Date

Kür Walde

Dr. Amir Waldman, VP Regulatory Affairs Home Skiovations Ltd.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

JAN 2 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Home Skinovations, Ltd. % Dr. Amir Waldman VP Regulatory Affairs Apolo Building, POB 533 Yokneam 20692 Israel

Re: K072906 Trade/Device Name: Silk'n Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 11, 2008 Received: January 17, 2008

Dear Dr. Waldman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Dr. Amir Waldman

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milherson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

Device Name___________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

Mark A. Millhem

(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative,

and Neurological Devices

510(k) Number