RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT

K051268 · Radiancy, Ltd. · GEX · Jul 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051268
• Device Name: RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
• Applicant: Radiancy, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 6, 2005
• 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 Acre 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 to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.

Device Story

The Radiancy Acne System is a dermatologic intense pulsed light (IPL) device. It utilizes a ClearTouch Light Unit Assembly (LUA) mounted onto existing Radiancy handpieces (SpaTouch or SkinStation). The system employs two green-coated flash lamps to deliver phototherapeutic light to the skin. It operates at a wavelength spectrum of 430–1100 nm, with a pulse duration of 35 msec and a 22 x 55 mm spot size. The device is used by clinicians to treat inflammatory acne vulgaris. By delivering light energy to the treatment area, the system aims to improve dermatological conditions, providing a non-invasive therapeutic option for patients.

Clinical Evidence

Clinical data provided demonstrates the device's ability to treat mild to moderate inflammatory acne vulgaris in patients with Fitzpatrick skin types I-VI, noting only minor side effects.

Technological Characteristics

Dermatologic IPL system; consists of two green-coated flash lamps; wavelength spectrum 430–1100 nm; pulse duration 35 msec; spot size 22 x 55 mm; handpiece-mounted assembly (SpaTouch or SkinStation platforms).

Indications for Use

Indicated for patients with mild to moderate inflammatory acne vulgaris, including pustular inflammatory acne, across Fitzpatrick skin types 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

• ClearLight Phototherapy System, Model CT 420

Submission Summary (Full Text)

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05/268 1 of 2

JUL 6 - 2005

## 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.<br>9 Gan Rave Street<br>Industrial Park |
|---------------|----------------------------------------------------------------|
| | Yavne<br>Israel |
| Telephone: | [phone] |
| Facsimile: | [phone] |

| Contact Person: | Jonathan S. Kahan, Esq.<br>Regulatory Counsel<br>Hogan & Hartson L.L.P.<br>555 Thirteenth Street, N.W.<br>Washington, D.C. 20004-1109<br>Telephone: [phone]<br>Facsimile: [phone]<br>Email: [e-mail] |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 27, 2005 |

#### Name of Device and Name/Address of Sponsor

| Trade/Proprietary Name: | Radiancy Acne System with ClearTouch™ Light Unit Assembly |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatologic Intense Pulse Light (IPL) System |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology (21 C.F.R. § 878.4810) |

- Radiancy (Israel) Ltd. Manufacturing Facility: 9 Gan Rave Street Industrial Park Yavne, Israel

| Establishment | |
|------------------------|---------|
| Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |

, I

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KOS128 2 of 2

#### Predicate Devices

Radiancy Acne System with ClearTouch™ Light Unit Assembly

ClearLight Phototherapy System, Model CT 420

#### Intended Use / Indications for Use

The Radiancy Acne System with ClearTouch™ Light Unit Assembly ("Radiancy Acre 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 to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.

#### 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 acne vulgaris (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 Indiancy Acne System with ClearTouch™ Light Unit Assembly and the ClearLight Phototherapy System, Model CL 420 ("ClearLight System"). The minor differences between the Radiancy Acne System and the ClearLight System do not raise new issues of safety and effectiveness. Clinical data demonstrates that the Radiancy Acne System treats mild to moderate inflammatory acne vulgaris in all skin types with only minor side effects. Thus, the Radiancy Acne System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of the department. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 6 - 2005

Radiancy Ltd. C/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P 555 13" Street N.W. Washington, District of Columbia 20004-1109

Re: K051268

K031200
Trade/Device Name: Radiancy Acne System with ClearTouch™ Light Unit Assembly 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: May 16, 2005 Received: May 16, 2005

Dear Mr. Kahan, Esq:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 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 101 use stated in the encreative to regists of the Medical Device Amendments, or to commerce pror to May 20, 1978, as accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (11ct) that do novice, subject to the general controls provisions of the Act. The r ou may, mercere, mains of the Act include requirements for annual registration, listing of general controll pro receive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (see as a ) throls. Existing major regulations affecting your device TDA it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Cours of Features concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dri 3 issual.co or cour device complies with other requirements of the Act that I DA has made a develiminations administered by other Federal agencies. You must of any I cach statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quiany of trol 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) This icter will anow your to ough finding of substantial equivalence of your device to a legally premarket nonnounce. "The sults 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 If you desire specific as a moliance at [phone] . Also, please note the regulation entitled, connact the Office of Computers on (Et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or 1911) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Muriam C. Provost

Miriam C. Provost, Ph.D. Acting 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): K051268

Device Name:

# Radiancy Acne System with ClearTouch™ Light Unit 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 System 71s michded to provide provide conditions. The Radiancy Acne System is Is gelicially indicated to treat mild to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.

Prescription Use __ X_

OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K05/268

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