OMNILUX BLUE

K030883 · Photo Therapeutics Limited · GEX · Jun 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030883
• Device Name: OMNILUX BLUE
• Applicant: Photo Therapeutics Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnilux Blue which is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Device Story

Omnilux Blue is a high-spectral-purity visible light source for dermatological treatment. Device consists of a base unit containing power supplies and control electronics, connected to three folding arms supporting an LED head. The LED head emits light at a wavelength of 415 ± 5 nm. The system is operated via an integrated LCD and keyboard interface. The device is used in a clinical setting to provide uniform, hot-spot-free illumination for the treatment of moderate inflammatory acne vulgaris. The healthcare provider positions the LED head over the patient's treatment area to deliver light therapy. The device does not involve complex diagnostic processing; it functions as a therapeutic light delivery system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on an analysis of performance characteristics.

Technological Characteristics

Visible light source using LED technology. Output wavelength: 415 ± 5 nm. Features a base unit with power supplies, control electronics, and three folding arms for positioning the LED head. Includes an LCD and keyboard for user interface and control of device functions.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris and general dermatological conditions.

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

• Lumenis Clearlight (K013623)

Submission Summary (Full Text)

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#### 1/2 K030883

## JUN 1 8 2003

## 510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux Blue

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: | March 18, 2003 |

2. Names

Device Name:

Classification Name:

Omnilux Blue

Laser Instrument, Surgical Powered Product Code: GEX Panel: 79

## 3. Predicate Devices

The Omnilux Blue is substantially equivalent to the Lumenis Clearlight (K013623).

### 4. Device Description

The Omnilux Blue is a 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 415 + 5 nm. The Omnilux Blue base unit contains the power supplies and the control 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

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K030883 2/2

the control electronics. The user interface software allows the operator to access and control all device functions.

- 5. Indications for Use
The Omnilux Blue which is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

## 6. Performance Data

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

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. . . . . . . . .

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

#### Public Health Service

JUN 1 8 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: K030883 Trade/Device Name: Omnilux Blue 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 19, 2003 Received: March 20, 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, 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 - 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 L. 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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# K030883

## 510(k) Number (if known)

Omnilux Blue Device Name_

### Indications for Use:

The Omnilux Blue is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use _________________________________________________________________________________________________________________________________________________________

000012

Miriam C. Provost

(Optional Format 1-2-96) (Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030883