OMNILUX RED

K030426 · Photo Therapeutics Limited · GEX · Jul 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030426
• Device Name: OMNILUX RED
• Applicant: Photo Therapeutics Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnilux Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

Device Story

Omnilux Revive is an intense visible light source providing uniform, non-thermal illumination for dermatological treatment. Device consists of a base unit containing power supplies and control electronics, connected to three folding arms supporting an LED head. Operator positions LED head over patient treatment area. Control unit features LCD and keyboard interface for parameter management. Device emits narrow-bandwidth light at 633 ± 5 nm. Used in clinical settings by healthcare professionals to treat superficial, benign vascular, and pigmented lesions. Output provides therapeutic light exposure to target skin areas.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Intense visible light source; LED-based; wavelength 633 ± 5 nm; narrow spectral bandwidth; uniform illumination; base unit with folding arms and LED head; LCD/keyboard control interface.

Indications for Use

Indicated for dermatology patients requiring treatment of superficial, benign vascular, and pigmented 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

• IPL Quantum SR (K020839)
• Aurora SR (K022266)
• EsteLux (K020453)

Submission Summary (Full Text)

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K030426

# JUL 17 2003 510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux Revive

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

| Submitter: | Photo Therapeutics Limited<br>Station House<br>Stamford New Road<br>Altrincham<br>Cheshire WA14 1EP<br>United Kingdom |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | May 6, 2003 |
| 2. | Names |
| Device Name: | Omnilux Revive |
| Classification Name: | Laser Instrument, Surgical Powered<br>Product Code: GEX<br>Panel: 79 |

### 3. Predicate Devices

The Omnilux Revive is substantially equivalent to a combination of the following devices: the IPL Quantum SR manufactured by Lumenis, Inc. and subject of K020839; the Aurora SR manufactured by Syneron Medical Ltd. and subject of K022266; and the EsteLux manufactured by Palomar Medical Technologies, Inc. and subject of K020453.

## 4. Device Description

The Omnilux Revive is an intense visible light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength is 633 ± 5 nm. The Omnilux Revive base unit contains the power supplies and the control

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unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

#### 5. Indications for Use

The Omnilux Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

#### Performance Data 6.

Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Therefore, the Omnilux Revive raises no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

JUL 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Photo Therapeutics Limited c/o Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K030426 Trade/Device Name: Omnilux Revive 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 6, 2003 Received: May 8, 2003

Dear Ms. O'Connell:

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. Iisting 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 - Ms. Maureen O'Connell

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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### 510(k) Number K030426

Device Name _________ Revive

Indications for Use:

The Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over The Counter Use

Miriam C. Provost(Optional Format 1-2-96)

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

510(k) Number K030426