SILK'N FLASH N GO

K103184 · Home Skinovations , Ltd. · OHT · Nov 10, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K103184
• Device Name: SILK'N FLASH N GO
• Applicant: Home Skinovations , Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Nov 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flash N Go device is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

Device Story

Silk'n Flash N Go is an over-the-counter pulsed light system for hair removal. Device consists of a base unit and handheld applicator. Operates by emitting light pulses to target hair follicles for permanent reduction in hair regrowth. Intended for home use by consumers. Healthcare providers do not operate the device; output is not used for clinical decision-making. Benefits include convenient, long-term hair reduction.

Clinical Evidence

Clinical data was collected in a prospective multisite clinical study. No specific performance metrics (e.g., p-values, CIs) were provided in the summary.

Technological Characteristics

Pulsed light hair removal system consisting of a base unit and handheld applicator. Complies with 21 CFR 1040.10 and 1040.11 performance standards for laser/light-based products.

Indications for Use

Indicated for over-the-counter removal of unwanted hair and permanent reduction in hair regrowth in individuals seeking long-term, stable reduction in hair counts following a treatment regime.

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

• Flash N Go (K082298)
• TRIA Laser Hair Removal System (K090820)
• EpiLight and PhotoDerm HR (K991935)

Submission Summary (Full Text)

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K103184/

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Home Skinovations Ltd. Silk'n Flash N Go

NOV 1 0 2010

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

### 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 Flash N Go |
|-------------------------|----------------------------------------------------------------------------------------------------------|
| 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

- Flash N Go (K082298), by Home Skinovations Ltd. .
- TRIA Laser Hair Removal System (K090820),by Tria Beauty, Inc. .
- EpiLight and PhotoDerm HR (K991935), by ESC Medical system Inc. �

#### Intended use:

The Flash N Go device is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

#### Device Description:

The Flash N Go hair removal system is a pulsed light system composed of a base unit and hand held applicator.

#### Performance data:

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 multisite clinical study.

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#### Substantial Equivalence:

The Flash N Go system is substantial equivalent to its predicate devices. The data in this 510k submission demonstrate that the Flash N Go system is identical to the cleared Flash N' Go, and shares the same intended use as other predicate devices. Therefore is substantial equivalent to its predicate devices. Details are provided in Substantial equivalent section 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 Flash N Go should raise no new issues of safety or effectiveness.

October 21, 2010

huis, wdu

Date

Dr. Amir Waldman, VP Regulatory Affairs Home Skinovations 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 stylized eagle with three wavy lines extending from its head, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.

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

Home Skinovations Ltd. % Dr. Amir Waldman Vice President, Regulatory Affairs Apolo Building, P.O. Box 533 Yokneam 20692, Israel

NOV 1 0 2010

Re: K103184

Trade/Device Name: Silk'n Flash N Go 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: October 21, 2010 Received: October 29, 2010

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. 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.

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Page 2 - Dr. Amir Waldman

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

D.V. or

Mark N. Melkerse Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)_KlO3184

#### Device Name_ Flash N Go

## Indications For Use:

NOV 1 0 2010

Flash N Go is an over the counter device intended for the removal of unwanted hair.

Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use X

Neil RE Oden Gar mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103184

(Optional Format 1-2-96)