RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY

K032205 · Radiancy (Israel) , Ltd. · GEX · Dec 11, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032205
• Device Name: RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
• Applicant: Radiancy (Israel) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes treatment of pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.

Device Story

Phototherapeutic device; utilizes two green-coated flash lamps to deliver light energy to skin. Input: electrical energy; Output: light spectrum 430-1100 nm. Handpiece-mounted assembly attaches to existing Radiancy SpaTouch or SkinStation platforms. Operated by clinicians in dermatological settings. Device delivers 35 msec pulses over 22 x 55 mm spot size. Output provides phototherapy to reduce inflammatory acne lesions; clinical benefit derived from light-based treatment of dermatological conditions.

Clinical Evidence

Clinical data provided to demonstrate efficacy in treating mild and moderate inflammatory acne, including pustular inflammatory acne, in patients with Fitzpatrick skin types I-IV.

Technological Characteristics

Consists of two green-coated flash lamps. Wavelength spectrum: 430-1100 nm. Pulse duration: 35 msec. Spot size: 22 x 55 mm. Mounts to existing SpaTouch or SkinStation handpieces. Energy source: electrical.

Indications for Use

Indicated for treatment of mild and moderate inflammatory acne, including pustular inflammatory acne, in patients with Fitzpatrick skin types I-IV.

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

• ClearLight Phototherapy System, Model CT 420

Submission Summary (Full Text)

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DEC 11 2003

### 510(k) SUMMARY

# Radiancy (Israel) Ltd.'s Radiancy Acne System with ClearTouch™ Light Unit Assembly

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Manufacturer:

Radiancy (Israel) Ltd.

13220.

9 Gan Ravve Street

Industrial Park

Yavne Israel

Telephone: [phone]

011 972-8-9438020 Facsimile:

Contact Person:

Jonathan S. Kahan, Esq.

Regulatory Counsel

Hogan & Hartson L.L.P.

555 Thirteenth Street, N.W.

Washington, D.C. 20004-1109

Telephone: [phone]

Facsimile: [phone]

Email: [e-mail] November 14, 2003

Date Prepared:

Name of Device and Name/Address of Sponsor

Trade/Proprietary Name: Radiancy Acne System with ClearTouch™ Light Unit Assembly

Dermatological Laser and Light Unit Assembly Common Name:

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#### KO32205 2/2

Classification Name:

Laser surgical instrument for use in general and plastic surgery and in dermatology (21 C.F.R. § 878.4810)

Manufacturing Facility:

Radiancy (Israel) Ltd. 9 Gan Ravve Street Industrial Park Yavne, Israel

#### Predicate Devices

## ClearLight Phototherapy System, Model CT 420

## Intended Use / Indications for Use

The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes treatment of pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.

# Technological Characteristics

The ClearTouch LUA is mounted on the hand piece of Radiancy's SpaTouch Photoepilation System (the "SpaTouch"), or on the hair removal / acne hand piece of Radiancy's SkinStation (the "SkinStation"), in order to treat inflammatory acne (the "Radiancy Acne System"). The Radiancy Acne System consists of two green-coated flash lamps. The Radiancy Acne System produces a wavelength spectrum of 430 - 1100 nm with a pulse duration of 35 msec and has a spot size of 22 x 55 mm.

### Substantial Equivalence

The Radiancy Acne System has the same intended use and very similar indications for use, principles of operation, and technological characteristics as the ClearLight Phototherapy System, Model CL 420 ("ClearLight System"). The minor differences between the Radiancy Acne System and the ClearLight System do not raise any new issues of safety and effectiveness. Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne which include pustular inflammatory acne in patients with Fitzpatrick skin types I-IV. Thus, the Radiancy Acne System is substantially equivalent.

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

DEC 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radiancy Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004

Re: K032205

KU3205
Trade/Device Name: Radiancy Acne System with ClearTouch™ Light Unit Asscmbly
Trade/Device Name: Radiancy Acne : a Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 24, 2003 Received: October 24, 2003

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or 10 conniner of prof to Hay 20, 2019 11:51 accordance with the provisions of the Federal Food, Drug. de neces that have been recuire approval of a premarket approval application (PMA). and Cosmetic rear (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, therefore, mans of the Act include requirements for annual registration, listing of general econtrols pro resuring 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 If your device is elabilition to vac controls. Existing major regulations affecting your device can may or saily to 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 r read o o a nove 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 or re rar 807), accesses (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.

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Page 2 - Mr. Jonathan S. Kahan, Esq.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

To Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 Indications for Use Form

| 510(k) Number (if known): | KO32205 |
|---------------------------|---------|
|---------------------------|---------|

Radiancy Acne System with ClearTouch™ Light Unit Device Name: Assembly

Indications for Use:

The Radiancy Acne System with ClearTouch Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild and moderate inflammatory acne which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X

OR

Over-The-Counter Use (Per 21 C.F.R. 801.109)

(Optional Format 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_K632205