SILKN BLUE

K121435 · Home Skinovations , Ltd. · OLP · Feb 22, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K121435
• Device Name: SILKN BLUE
• Applicant: Home Skinovations , Ltd.
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Feb 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

Device Story

Silkn Blue is a handheld, battery-operated phototherapy device for home use. It utilizes a 415 nm (±15 nm) LED light source combined with a tip temperature stabilizer to treat mild to moderate acne. The device delivers 50 mW/cm2 of optical power with a uniform distribution. During operation, the tip maintains a temperature of 41°C (±2°C). The user applies the device to the skin; the combination of blue light and thermal energy targets acne. Clinical benefits include reduction in inflammatory lesion counts. The device is intended for self-administration by the patient.

Clinical Evidence

Clinical study of 50 subjects using the device twice weekly for four weeks (8 treatments) with 3-month follow-up. Primary endpoint was reduction in inflammatory acne lesion count. Results showed 56.7% average improvement after one month, maintained at 57.7% (±9.4%) after 3 months. No adverse effects reported. Usability research confirmed the ability of the average user to operate the device according to labeling.

Technological Characteristics

Handheld, battery-operated LED phototherapy device. Wavelength: 415 nm. Power: 50 mW/cm2. Tip temperature stabilizer maintains 41°C. Patient-contact materials: Stainless steel 17-4PH and rigid ABS plastic. Complies with 21 CFR 1040.10 and 1040.11. No software-based algorithm described.

Indications for Use

Indicated for treatment of mild to moderate acne in patients using the device over-the-counter.

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

• ThermaClear by DermaCare Inc. (K060653)
• Quasar Blue Light Therapy System by Silver Bay LLC (K093963)
• Tanda Skincare System by Pharos Life Corporation (K080591)
• OmniLux New-U by Photo Therapeutics Inc (K081307)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Home Skinovations Ltd. Silkn Blue

FEB 2 2 2 2013

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: | Tavor building, POB 533, Yokneam 20692, Israel |
| Contact: | Dr. Amir Waldman VP Regulatory Affairs |

#### Device information

| Trade/Proprietary name: | Silkn Blue |
|-------------------------|------------------------------------------------------------------------|
| Common/Usual name: | Acne Treatment device |
| Classification name: | Over the counter powered light based laser for Acne, 2<br>CFR 878.4810 |
| Product code: | OLP |

#### Predicate devices

- . ThermaClear by DermaCare Inc. K060653.
- Quasar Blue Light Therapy System by Silver Bay LLC, K093963. .
- Tanda Skincare System, by Pharos Life Corporation, K080591 .
- . OmniLux New-U, by Photo Therapeutics Inc, K081307.

### Intended use:

The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

### Device Description & technology comparison to predicate device:

Silkn Blue is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 415 ±15 nm, combine with tip temperature stabilizer at 41ºC. The emitting optical power is in a uniform distribution with no hot spots.

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| | Silkn Blue | ThermaClear | Quasar<br>Blue | Tanda<br>Skincare | OmniLux<br>Clear-U |
|------------------------------------|---------------------------------------------|----------------------------------|----------------|-------------------|----------------------------|
| Energy<br>Source | LED + Tip<br>temperature<br>stabilizer | Tip<br>temperature<br>stabilizer | LED | LED | Dual<br>wavelengths<br>LED |
| Wavelengths<br>(nm) | 415 | NA | 415 | 415 | 415, 633 |
| Power<br>mW/cm2 | 50 | NA | 50 | 50 | 40(415 nm),<br>70(633 nm) |
| Treatment<br>area cm2 | 7 | 1 | 10 | 27 | 30 |
| Targeted skin<br>temperature<br>°C | 41±2 | 41-43 | 39-43 | 39-43 | 39-43 |
| Patient<br>contacting<br>material | Stainless<br>steels<br>17-4PH, Rigid<br>ABS | Stainless steels | Rigid<br>ABS | Rigid<br>ABS | Rigid ABS |

Technology comparison of Silkn Blue with predicate devices:

#### Performance data:

The device complies with the following U.S. Food and Drug Administration performance standards: 21CFR § 1040.10 & 1040.11

#### Clinical study summary:

The clinical and usability research study performed to determine the ability of the Silkn Blue device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as describe in the operator manual.

The clinical study involves 50 subjects who used the Silk'n Blue twice a week over four weeks (a total of 8 treatments), and 2 follow-up visits to evaluate the results. All subjects demonstrated a reduction in lesion count.

The average improvement after one month was 56.7% and remained similar also after 3 months 57.7%±9.4%.

The users were asked to fill a questionnaire regarding the device use and labeling. Safety was evaluated by monitoring immediate reaction and adverse effects. There were no other adverse effects associated with the treatment.

#### Substantial Equivalence:

The Silkn Blue is substantial equivalent to its predicate device. The data in this 510(k) submission demonstrate that the Silkn Blue device has compatible output as the predicate devices, and identical intended use. Therefore is substantial equivalent to its predicate devices.

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

May 10, 2012

પ્રદર્ભ

Date

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

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

#### Public Health Service

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

February 22, 2013

Home Skinovations, Limited % Dr. Amir Waldman Vice President, Regulatory Affairs Tavor Building, POB 533 Yokneam Illit, Israel 20692

Re: K121435

Trade/Device Name: Silkn Blue 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: OLP Dated: January 09, 2013 Received: February 13, 2013

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.

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

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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.

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/ResourcesforYou/Industry/default.htm.

> Sincerely yours, For:

## Peter Di Rumm -S Mark

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)_K_121435

Device Name_Silkn Blue

Indications For Use:

The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogder 2013.02.21 15 34:39 -05.00

(Division Sign-Off)

Division of Surgical Devices

510(k) Number _ K121435