RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY

K052442 · Radiancy (Israel) , Ltd. · GEX · Jan 26, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052442
• Device Name: RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY
• Applicant: Radiancy (Israel) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SkinStation® is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I-VI, and mild to moderate psoriasis in patients with Fitzpatrich skin types I-VI.

Device Story

The Radiancy SkinStation is a pulsed light system used for dermatological phototherapy. The device utilizes a modified light unit assembly (LUA) to deliver light energy to the skin. It is operated by healthcare professionals in a clinical setting. The device transforms electrical energy into therapeutic pulsed light, which is applied to the patient's skin to treat specific conditions such as psoriasis, acne, vascular lesions, and pigmented lesions. The clinician uses the device to deliver targeted phototherapy, which can help manage dermatological symptoms and improve patient outcomes. The system is designed for use on patients across all Fitzpatrick skin types (I-VI).

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and comparison to legally marketed predicate devices.

Technological Characteristics

Pulsed light system; modified light unit assembly (LUA) for psoriasis treatment. Operates as a laser surgical instrument (21 C.F.R. § 878.4810).

Indications for Use

Indicated for hair removal, treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris (including pustular acne), and mild to moderate psoriasis in patients with 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

• Radiancy SkinStation Systems
• Cooltouch Prima IPL system
• Candela, Inc. C-Beam dye laser
• Lumenis, Inc., BClear™ lamp
• CureLight, Ltd., MultiClear lamp
• MSQ ("M2") Ltd. Lovely II IPL UV lamp
• Cutera Optional Pulsed Light Hand Piece (K050047)

Submission Summary (Full Text)

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## JAN 2 4 2006

K 052442

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#### 510(k) SUMMARY

# Radiancy (Israel) Ltd.'s Radiancy SkinStation® with Modified Light Unit Assembly for Psoriasis Treatment

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

- Manufacturer: Radiancy (Israel) Ltd. 9 Gan Rave Street Industrial Park Yavne lsrael Telephone: [phone] Facsimile: [phone]
- Contact Person: Margaret R. Fourte Director, Clinical and Regulatory Affairs Radiancy, Inc. 40 Ramland Road, Suite 10 Orangeburg, NY 10962 Telephone: [phone] Facsimile: [phone] Email: [e-mail]
- Date Prepared: September 2, 2005

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

| Trade/Proprietary Name: | Radiancy SkinStation® with Modified LUA |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Pulsed Light System and Light Unit Assembly |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology (21 C.F.R. § 878.4810) |

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

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

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#### Predicate Devices

Radiancy SkinStation Systems

Cooltouch Prima IPL system (predicate for Cutera Pulsed Light Hand Piece)

Candela, Inc. C-Beam dye laser

Lumenis, Inc., BClear™ lamp

CureLight, Ltd., MultiClear lamp

MSQ ("M2") Ltd. Lovely II IPL UV lamp

#### Intended Use / Indications for Use

The SkinStation® is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I-VI, and mild to moderate psoriasis in patients with Fitzpatrich skin types I-VI.

#### Technological Characteristics

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for the treatment of psoriasis in patients with Fitzpatrick skin types I - VI.

#### Substantial Equivalence

The Radiancy SkinStation, as modified, has the same intended use and very similar indications for use, principles of operation and technological characteristivs as the cleared Radiancy SkinStation, and the Cooltouch Prima IPL system, Candelanonoo G-Beam dye laser, Lumenis, Inc., BClear™ lamp, CureLight, Ltd., MultiClear lamp and the MSQ ("M2") Ltd. Lovely II IPL UV lamp. The new psoriasis indication for use is based upon the indications for use for two already cleared predicate pulsed light device Systems PRIMA IPL and the Cutera, Inc. Cutera Optional Pulsed Light Hand Piece (PRIMA is the predicate device for the cleared Cutera Optional Pulsed Light Hand Piece Family (K050047) [Attachment 4]. The minor differences between the Radie nay SkinStation and the predicates do not raise new issues of safety and effectiveness. Thus, the Radiancy SkinStation is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a stylized eagle with three lines forming its body and wings, and two curved lines representing its legs. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" in a circular arrangement.

Public Health Service

JAN 2 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret R. Fourte Director, Clinical and Regulatory Affairs Radiancy. Inc. 40 Ramland Road South, Suite 10 Orangeburg, New York 10962

Re: K052442

Trade/Device Name: Radiancy SkinStation® with Modified Light Unit Assembly for Psoriasis 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: December 22, 2005 Received: December 23, 2005

Dear Ms. Fourte:

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 - Ms. Fourte

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 Clille 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 3 legal|y 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" (21 CFR Part 807.97). Your my nhtnin other general information on your responsibilities under the Act from the Division of Sooll 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.

Stupt Cuvels

, Mark N. Melkerson 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

# Device Name: Radiancy SkinStation® with Modified Light Unit Assembly for Psoriasis

Indications for Use:

The SkinStation® is intended to provide phototherapeutic light to the body and is generally indicated to treat dematological conditions. The SkinStation is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types In Fitz, and mild to moderate more included publicities with Fitzpatrick 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)

Stupt Purdy

(Division Si 2-Off Division of Ceneral, Restorative, and Neurological Devices

510(k) Number --KOSZ442