OMNILUX CLEAR-U

K081307 · Photo Therapeutics, Inc. · OLP · Jan 16, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K081307
• Device Name: OMNILUX CLEAR-U
• Applicant: Photo Therapeutics, Inc.
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Jan 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face

Device Story

Omnilux Clear-U is a light-based device for home use; emits high spectral purity light in red (633 ± 6 nm) and blue (415 ± 5 nm) wavelengths. Device consists of LED array assembly, selector switch for wavelength selection, and air cooling system; powered by external universal AC/DC power supply. Operator controls treatment time. Intended for patient self-use to treat mild to moderate acne on the face. Benefits include non-invasive light therapy for acne management.

Clinical Evidence

No clinical efficacy data provided. Evidence consists of bench testing and human factors validation: self-selection study (93% comprehension rate, 95% CI) and usability study (88% comprehension rate, 95% CI) conducted on representative populations using product labeling.

Technological Characteristics

LED-based light source; red (633 ± 6 nm) and blue (415 ± 5 nm) wavelengths. Features selector switch, LED array, and air cooling. Powered by external universal AC/DC power supply. Designed for home use.

Indications for Use

Indicated for treatment of mild to moderate facial acne in 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 blue (K030883)
• Omnilux revive/Omnilux blue combination (K043329)

Submission Summary (Full Text)

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K081307 Pg 1 of 2

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

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

# JAN 1 6 2009

| Submitter: | Photo Therapeutics Inc<br>2720 Loker Avenue West<br>Carlsbad<br>California<br>CA 92010 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sue Darcy<br>CEO<br>Photo Therapeutics Inc<br>2720 Loker Avenue West<br>Carlsbad<br>California<br>CA 92010<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Summary Preparation Date: | 18 ^th May 2007 |
| Amended: | 20 ^th July 2007 (Contact Person corrected) |

2. Names

| Device Name: | Omnilux Clear-U |
|----------------------|-------------------------------------------------------------------------------------|
| Classification Name: | Laser Instrument, Surgical Powered - General and Plastic<br>Surgery - Class II, OLP |

Although this device is not a laser and is intended for OTC use, the manufacturer thinks this is the closest applicable classification name.

## 3. Predicate Devices

Omnilux Revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329).

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K081307

#### 4. Device Description

The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-U Treatment time is controlled by the operator

### 5. Indications for Use

The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face The target patient population for the Omnilux Clear-U is the same as that for the predicate devices, however the Omnilux Clear-U 1s designed for home use

### 6. Performance Data

Photo Therapeutics Limited believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329) and the Omnilux Clear-U Therefore, the Omnilux Clear-U raises no new issues of safety or effectiveness

This belief is based upon

- An analysis of the overall performance characteristics for the device .
- The results of a self-selection test (carried out on a sample representative . population using the product labeling) which showed a mınımum comprehension rate for the critical objectives of 93% at the 95% confidence level
- The results of a usabılıty test (carried out on a sample representative population . using the product labeling) which showed a minimum comprehension rate for the critical objectives of 88% at the 95% confidence level

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2009

Photo Therapeutics, Inc % Ms Sue Darcy CEO 2720 Loker Avenue West Carlsbad, California 92010

Re K081307 Trade/Device Name Omnilux Clear-U 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 OLP Dated December 23, 2008 Received December 29, 2008

Dear Ms Darcy

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 regustration, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

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

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Page 2 - Ms Sue Daicy

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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at [phone] For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone] You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assıstance at its toll-free number [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours.

Mark N. Mulhearn

Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K081307 pg 1041

Device Name

### Indications for Use

The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face

Prescription Use (Per 21 CFR 801 109)

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AND/OR

Over the Counter Use &

1

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K081307