OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM

K032191 · Luxsano AB · GEX · Aug 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032191
• Device Name: OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
• Applicant: Luxsano AB
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OmniLight FPL System is intended to be used in the following procedures: - 1. Hair Removal in all Skin types according to the Fitzpatrick Scale - 2. Permanent Hair reduction - 3. Treatment of Vascular Lesions - 4. Treatment of Pigmented Lesion - 5. Tattoo Removal

Device Story

OmniLight Fluorescent Pulsed Light System delivers pulsed light (wavelengths ≥515 nm) for dermatological procedures. Device comprises cabinet (power supply, cooling system, microcontroller), umbilical, and handpiece (waveguide). Operated by clinicians in dermatology/plastic surgery settings. System uses pulsed light energy to target hair follicles, vascular lesions, pigmented lesions, and tattoo pigments. Clinical benefit includes hair reduction and lesion/tattoo treatment. Microcontroller manages energy delivery and cooling parameters.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intense Pulsed Light (IPL) system; wavelengths ≥515 nm; includes power supply, cooling system, microcontroller, and handpiece with waveguide. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for hair removal in all Fitzpatrick skin types, permanent hair reduction, treatment of vascular lesions, treatment of benign pigmented lesions, and tattoo removal.

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

• ProLite (K013365)
• Plasmalite MPX Pulsed Light System (K022569, K022568, K023081)

Submission Summary (Full Text)

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K032191 191

## AUG 2 0 2003

## 510(K) Summary OmniLight Fluorescent Pulsed Light System

This 510(K) Summary of safety and effectiveness for the OmniLight Pulsed Light System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Luxsano AB |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Lona Knapes gata 5<br>421 32 Vastra Frolunda,<br>Sweden |
| Contact Person: | Connie White Hoy |
| Telephone / Fax / Email | 46.31.709.30.70 - Phone<br>46.31.709.30.79 - Fax<br>[e-mail] |
| Preparation Date: | May 5, 2003 |
| Device Trade Name: | OmniLight Fluorescent Pulsed Light System |
| Common Name: | Intense Pulsed Light |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | ProLite and Plasmalite MPX Pulsed Light System<br>K number(s) 013365, 022569, 022568, 023081 |
| Description of the OmniLight Fluorescent<br>Pulsed Light System | The OmniLight Fluorescent Pulsed Light System delivers<br>pulsed light at wavelengths starting at 515 nanometers. The<br>device consists of three interconnected sections: The cabinet<br>which houses the power supply, the cooling system and the<br>microcontroller, the umbilical to the handpiece, and the<br>handpiece, which houses the waveguide |
| Intended use of the OmniLight Fluorescent<br>Pulsed Light System | The OmniLight Fluorescent Pulsed Light System is<br>indicated for the following:<br><br>Hair removal in all skin types<br>Permanent hair reduction<br>Treatment of Vascular Lesions<br>Treatment of Benign pigmented lesions<br>Tattoo removal |
| Performance Data: | None |
| Conclusion: | The OmniLight Pulsed Light System is substantially<br>equivalent to other existing pulsed light systems in<br>commercial distribution in Dermatology and Plastic<br>Surgery. |

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Image /page/1/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 lines representing its wings and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2003

Luxsano AB c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776

Re: K032191 Trade/Device Name: OmnoLight FPL System 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 5, 2003 Received: July 29, 2003

Dear Ms. Hoy:

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 (OS) 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. Connie White Hoy

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]. 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 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,

Mark N. Millenson
©Sadie McWitter, Ph.D., M.D.

elia M. Witten, Ph.D., M Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number: ___ fending_ KO3Q19

Device Name: OmniLight FPL System

Indications for Use:

The OmniLight FPL System is intended to be used in the following procedures:

- 1. Hair Removal in all Skin types according to the Fitzpatrick Scale
- 2. Permanent Hair reduction
- 3. Treatment of Vascular Lesions
- 4. Treatment of Pigmented Lesion
- 5. Tattoo Removal

Mark N. Mullerson

Division of General, Restorative and Neurological Devices

510(k) Number K032191

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

OR

Over-the-Counter Use ------------------------------------