SPR SYSTEM

K033181 · Radiancy (Israel) , Ltd. · GEX · Oct 24, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033181
• Device Name: SPR SYSTEM
• Applicant: Radiancy (Israel) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.

Device Story

The SPR System is a pulsed light device used for light therapy. It delivers light energy to the body to treat pigmented and vascular lesions. The device is operated by a clinician in a professional setting. It functions by emitting pulses of light to target specific skin conditions. The output is the application of light therapy, which is intended to address the specified lesions. The device is substantially equivalent to the SkinStation system, utilizing the same operational principles for its pigmented and vascular lesion modules.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological identity to the predicate device.

Technological Characteristics

Pulsed light device. Operates as a laser surgical instrument (21 CFR 878.4810). Functionally identical to the predicate SkinStation system for pigmented and vascular lesion treatment.

Indications for Use

Indicated for treatment of pigmented and vascular lesions in patients requiring light therapy.

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

• SkinStation® System (K030897)

Submission Summary (Full Text)

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OCT 2 4 2003

# Kossia I of 2

# 510(k) SUMMARY

### Radiancy (Israel) Ltd.'s SPR System

## 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]

Date Prepared:

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

| Trade/Proprietary Name: | SPR™ System |
|------------------------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Pulsed Light System |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR § 878.4810) |
| Address of Manufacturing Facility: | Radiancy (Israel) Ltd.<br>9 Gan Ravve Street<br>Industrial Park<br>Yavne, Israel |

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K031891 2 of 2

Establishment Registration Number: Owner/operator number:

9616256 9040071

### Predicate Devices

Radiancy's SkinStation® System (K030897)

### Intended Use / Indications for Use

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.

#### Technological Characteristics and Substantial Equivalence

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions. The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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OCT 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033181

Trade/Device Name: SPR™ 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: September 30, 2003 Received: October 1, 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 - Mr. Jonathan S. Kahan

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

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):

K033181

SPR™ System Device Name:

Indications for Use:

The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated 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 _____________________________________________________________________________________________________________________________________________________________

OR

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

Miriam C. Provost

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

(Optional Format 1-2-96)

510(k) Number K033181

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