SKINSTATION

K030897 · Radiancy (Israel) , Ltd. · GEX · Jun 19, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030897
• Device Name: SKINSTATION
• Applicant: Radiancy (Israel) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.

Device Story

SkinStation is a pulsed light system for hair removal and treatment of pigmented and vascular lesions. Device utilizes pulsed light energy delivered via handpieces; hair removal mode uses technology identical to SpaTouch; SPR module enables treatment of pigmented and vascular lesions. System is technologically similar to Lumenis IPL Quantum SR, Medical Bio Care Prolite, and Palomar EsteLux. Device is intended for clinical use.

Clinical Evidence

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

Technological Characteristics

Pulsed light system; includes SPR handpiece for pigmented and vascular lesions. Operates as a laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for hair removal and treatment of pigmented and vascular lesions.

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

• SpaTouch Hair Removal System
• Lumenis IPL Quantum SR
• Medical Bio Care Sweden's Prolite
• Palomar's EsteLux

Submission Summary (Full Text)

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# JUN 1 9 2003

### 510(k) SUMMARY

# Radiancy (Israel) Ltd.'s SkinStation™ System

K030997

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

Radiancy (Israel) Ltd. 9 Gan Ravve Street Industrial Park Yavne lsrael Telephone: [phone] Facsimile: [phone]

Jonathan S. Kahan, Esq. Contact Person: Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: [phone] Facsimile: [phone] Email: [e-mail]

March 19, 2003 Date Prepared:

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

| Trade/Proprietary Name: | SkinStation™ System |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Pulsed Light System |
| Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology (21 CFR §<br>878.4810) |

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| Address of Manufacturing Facility: | Radiancy (Israel) Ltd. |
|------------------------------------|------------------------|
| | 9 Gan Ravve Street |
| | Industrial Park |
| | Yavne, Israel |
| Establishment Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |

# Predicate Devices

Radiancy's SpaTouch Hair Removal System Lumenis IPL Quantum SR Medical Bio Care Sweden's Prolite Palomar's EsteLux.

# Intended Use / Indications for Use

The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.

### Technological Characteristics and Substantial Equivalence

The SkinStation is a pulsed light device intended for hair removal and treatment of pigmented and vascular lesions. When operated in the hair removal mode, the Skin Station is identical to the previously cleared SpaTouch, except that it is now housed with the SPR module for treating pigmented and vascular lesions. When operated in the pigmented and vascular lesions mode (i.e., using the SPR handpiece), the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the cleared Quantum, with a few exceptions which do not raise new issues of safety and effectiveness. In addition, the SkinStation has the same intended use, with similar indications for use, and is technologically similar to the previously cleared MBC's Prolite and Palomar's EsteLux when operated in the SPR mode

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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 the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and care. The profiles are black against a white background.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Radiancy (Israel) Ltd. c/o Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Re: K030897 Trade/Device Name: SkinStation™ System 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: March 21, 2003 Received: March 21, 2003

Dear Mr. Kahan:

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 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.

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Page 2 - 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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

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): K030897

Device Name:

SkinStation™ System

Indications for Use:

The SkinStation is a pulsed light device intended for hair removal and for treatment of pigmented and vascular lesions.

(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

Miriam C. Provost

(Optional Format 1-2-96)

(Per 21 C.F.R. 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

510(k) Number K030897

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