OMNILUX REVIVE AND OMNILUX PLUS

K050216 · Photo Therapeutics Limited · GEX · Aug 9, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050216
• Device Name: OMNILUX REVIVE AND OMNILUX PLUS
• Applicant: Photo Therapeutics Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Device Story

The Omnilux Revive and Omnilux Plus Combination is a light-based dermatological device providing high spectral purity illumination. The system consists of a base unit containing power supplies and control electronics, connected to three folding arms that support LED heads. The device emits red light (633 ± 5 nm) and infrared light (830 ± 5 nm) to treat periorbital wrinkles. It is operated by a clinician in a clinical setting. The operator uses an LCD and keyboard interface to control device functions via software. The device provides uniform, non-thermal illumination to the target area. By delivering specific wavelengths of light, the device is intended to improve the appearance of periorbital wrinkles, offering a non-invasive treatment option for patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on an analysis of performance characteristics and comparison to previously cleared predicate devices.

Technological Characteristics

The device utilizes LED-based light sources providing high spectral purity at 633 nm and 830 nm. It features a base unit with power supplies, control electronics, and three folding arms for positioning LED heads. The system includes an LCD and keyboard for user control. The device is a non-laser, powered surgical/dermatological instrument.

Indications for Use

Indicated for the treatment of periorbital wrinkles in dermatology patients.

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

• Omnilux Revive (K030426)
• Omnilux Plus (K043317)

Submission Summary (Full Text)

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K050216

# 510(k) Summary of Safety and Effectiveness for the Photo Therapoutics Limited Omnilux Plus

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This 510(k) Summary of Safety and Ellcctiveness 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: | Steve Hutson<br>Director of Engineering and Regulatory<br>Affairs<br>Photo Therapeutics Limited<br>Station House<br>Stamford New Road<br>Altrincham<br>Cheshire WA14 1EP<br>United Kingdom<br>T: [phone]<br>F: [phone] |
| Summary Preparation Date: | December 10th, 2004 |
| Device Name: | Omnilux Revive and Omnilux Plus<br>Combination |
| Classification Name: | Omnilux Revive - Laser Instrument,<br>Surgical Powered - General and Plastic<br>Surgery - Class II, 79-GEX<br>Although this device is not a laser, the<br>manufacturer thinks this is the closest<br>applicable classification name.<br>Omnilux Plus - Lamp, Infrared - Physical<br>Medicine - Class II, 89-ILY, 890.5500 |

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#### 3. Predicate Devices

Predicate devices for the Omnilux Revive and the Omnilux Plus were detailed in ; K030426 and 510K submission K043317 respectively.

## 4. Device Description

The Omnilux Revive and Omnilux Plus are two sources of high spectral purity. They provide uniform or "hot-spot" free illumination. The outputs are pre-tuned to one wavelength with a narrow spectral bandwidth. The output of the Omnilux Revive is 633 + 5 nm, and the output of the Ommilux Plus is 830 + 5 nm. The 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 ams and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control clectronics. The user interface software allows the operator to access and control all device functions.

### 5. Indications for Use

The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the rod and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

#### Performance Data 6.

Based upon an analysis of the overall performance characteristics for the dovice, Photo Therapeutics Limited believes that no significant differences exist between the Omnilux Revive and the Omnilux Plus Combination, the previously approved Omnilux Revive (K030426) and the Omnilux Plus (which is the subject of 510K submission K043317). Therefore, the Omnilux Revive and Omnilux Plus Combination raises no new issues of safety or effectivencss.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

AUG 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Hutson Director of Engineering and Regulatory Affairs Photo Therapeutics Limited Station House, Stamford New Road Altrincham Cheshire WA 14 1EP United Kingdom

Re: K050216

Trade/Device Name: Omnilux Revive and Omnilux Plus Combination 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: June 16, 2005 Received: June 22, 2005

Dear Mr. Hutson:

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 for association 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. Steve Hutson

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ocgin mailoung of substantial equivalence of your device to a legally premaired predicated 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 If you desire specific acrroliance at [phone]. Also, please note the regulation entitled, Conact the Office of Compulance as (21 t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionation on 900 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,
Barbara Buekins
for

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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Omnilux Revive and Omnilux Plus Combination Device Name_

Indications for Use: 《ζΟΣΟΣΟΣΟΣΟΣ

The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Prescription Use _X (Per 21 CFR 801.109)

AND/OR

Over The Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Boutwell Buchard for Mark Meiterson

al. Restorative and Neurological Devic

510(k) Number