OMNILUX REVIVE AND BLUE

K043329 · Photo Therapeutics Limited · GEX · Mar 18, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043329
• Device Name: OMNILUX REVIVE AND BLUE
• Applicant: Photo Therapeutics Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnilux Revive and Blue Combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

Device Story

Device emits red and blue light energy for dermatological treatment; specifically mild to moderate acne vulgaris. System comprises base unit containing power supplies and control unit, with three attached focusing arms. User interface includes LCD and keyboard for controlling device functions. Arms are positioned by user to direct light output onto patient skin. Device provides uniform, non-hot-spot spectral output. Pre-tuned wavelengths: Revive (633 ± 3 nm) and Blue (415 ± 5 nm). Used in clinical settings; operated by healthcare professionals.

Clinical Evidence

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

Technological Characteristics

Light-emitting diode (LED) based system. Wavelengths: 633 ± 3 nm (Revive) and 415 ± 5 nm (Blue). Form factor: Base unit with three adjustable focusing arms. User interface: LCD and keyboard. Energy source: Electrical power supply. Device is a combination of two previously cleared light sources.

Indications for Use

Indicated for the treatment of mild to moderate acne vulgaris 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)
• IPL Quantum SR (K020839)
• Aurora SR (K022266)
• EsteLux (K020453)
• Lumenis ClearLight (K013623)

Submission Summary (Full Text)

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K043329 1 of 2

MAR 1 8 2005

## 510(k) Summary of Safety and Effectiveness for the STO(R) Suinmal y of Survey and Revive and Blue Combination

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with a
reas and Effective 1000 mm 1.01 Climp 207 02 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 |
| | Summary Preparation Date: | November 17th, 2004 |
| 2. | Names | |
| | Device Name: | Omnilux Revive and Blue Combination |
| | Classification Name: | Laser Instrument, Surgical powered<br>Product Code: GEX<br>Panel: 79 |

### 3. Predicate Devices

Predicates for the Omnilux Revive and Omnilux Blue were detailed in K030426 and K030883 respectively, but the predicates are listed below for completeness.

Omnilux Revive is substantially equivalent to ... IPL Quantum SR manufactured by Lumenis, Inc. (K020839) Aurora SR manufactured by Syneron Medical Ltd.(K022266) EsteLux manufactured by Palomar Medical Technologies, Inc. (K020453)

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#### 2 K043329

Omnilux Blue is substantially equivalent to ... Lumenis ClearLight (K013623).

### 4. Device Description

The Omnilux Revive and Blue is a combination of two sources of high spectral
ed the outs of the count the tast the supplies of the two output a The Omnilux Revive and Blue is a compination. The two output are
purity. They provide uniform or "hot-spot" headwidth. The output purity. They provide unitoin of the spectral bandwidth. The output
pre-tuned to one wavelength with a narcow spectral bandwidth: Rlue is 415 + 2 pre-tuned to one wavelength with a nation specular Blue is 415 + 5m.
wavelength of Omnilux Revive is 63 + 5 mm, and Omnilux Blue is 415 + 5m. wavelength of Ommilux Revive Is 055 ± 3 min, in supplies and the control unit. Attached
The Omnilux base unit contains the III I FD hose same attached to the end The Omnilux base unit contains the power expenses . The control unit consists on to the base unit are inree foruing annis. The econtrol unit consists of
of the arms and then positioned for patient to the lesting. The user interface of the arms and then positioned for parterials. The user interface
an LCD and keyboard together with the control devices functions an LCD and Reyboard together while the reasonal control all device functions.

#### 5. Indications for Use

The Omnilux Revive and Blue Combination is intended to emt energy in the red The Omninux Revive and Drac Contrainer
and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

#### 6. Performance Data

Based upon an analysis of the overall performance characteristics for the device, Based upon an analysis of the overal pot no significant differences exist between
Photo Therapeutics Limited believes that no significant differences exist between Photo Therapedites Enmited Seneves ination' and the previously approved the Onlinex Revive (K030426) and Omnilux Blue (K030883) devices and their Omnilux Revive (R050+20) and Onlines Revive and Blue Combination raises no new issues of safety or effectiveness.

The new intended use is detailed in Appendix 1.

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Public Health Service

MAR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Hutson MI. Btoroff Engineering and Regulatory Affairs Photo Therapeutics Ltd. Station House Stamford New Road Altrincham Cheshire WA14 1EP United Kingdom

Re: K043329

K043329
Trade/Device Name: Omnilux Revive and Blue 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: February 1, 2005 Received: February 7, 2005

Dear Mr. Hutson:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section - ro(x) premained is substantially equivalent (for the indications referenced above and nave determined the acteed predicate devices marketed in interstate for use stated in the enclosure) to regary manced provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Drug commerce prior to May 20, 1970, the charment and be provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provision application (PM devices that have been recassified in acceraated in a premarket approval applications (PMA).
and Cosmetic Act (Act) that do not require approval or suisions of the Act . The and Cosment Act (Act) that to hot require approvince so the general controls, provisions of the Act. The You may, merelore, market the device, saojost to annual registration, listing of
general controls provisions of the Act include requirements for annual registration, word general controls provisions of the Act merade requires.
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 class If your device is classified (SCC above) nike existing mass regulations affecting your device can
may be subject to such additional controls. Existing may of a policy and th may be subject to such additional controller in thisting in your and to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Code of Pederal Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualler of a substance organics with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemmanon alae Jour are Jour accred by other Federal agencies. You must li or any Federal statures and regulations adminting, but not limited to: registration and listing ( 2 l
ever state all the Act's requirements, including, but not limited to: se comply with an the Act s requirements, mercanse, a
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice also akatest CFK Part 807), labeling (21 CFR Part 800), government (20); and if applicable, the electronic forth in the quality systems (QU) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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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 will anow you to begin maneting of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalse and the p premarket notification. The PDA miding of substantal equive 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
r and the may be and 115 and has and any and as a the requiries weritled If you desire specific advice for your at 110 mm. Also, please note the regulation cutitled.
contact the Office of Compliance at [phone]. Also, please note the open ob contact the Office of Compliance at (210) 276 or 1 (21CFR Part 807.97). You may obtain " Misbranding by reference to premance notification of Set from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 638other general Informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Consumer Assibuner as to to to to to to to the new support/index.html.

Sincerely yours.

Miriam C. Provost, Ph.D. 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 Blue Combination_ Device Name___________________________________________________________________________________________________________________________________________________________________

# Indications for Use:

The Omnilux Revive and Blue Combination is intended to emit energy in the red and The Omnilux Revive and Blue Combination is michael to offically indicated to treat mild to moderate acne vulgaris.

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

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Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR

Over The Counter Use _________________________________________________________________________________________________________________________________________________________

Signature

(Optional Format 1-2-96)

opiorative

043329