PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS

K013365 · Medical Bio Care Sweden AB · GEX · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013365
• Device Name: PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
• Applicant: Medical Bio Care Sweden AB
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProLite Pulsed Light System is intended for the treatment of benign pigmented lesions and the removal of tattoos.

Device Story

ProLite Pulsed Light System delivers pulsed light at 550 nm wavelength for dermatological applications. Device comprises three interconnected sections: cabinet housing power supply, cooling system, and microcontroller; umbilical cable; and handpiece containing waveguide. Operated by clinicians in dermatology or plastic surgery settings. System uses light energy to target benign pigmented lesions and tattoos. Output is controlled by internal microcontroller. Clinical benefit includes removal of tattoos and treatment of pigmented lesions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Pulsed light system operating at 550 nm wavelength. Consists of a cabinet (power supply, cooling system, microcontroller), umbilical, and handpiece with waveguide. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for the treatment of benign pigmented lesions and the removal of tattoos in patients undergoing dermatological or plastic surgery procedures.

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

• Photoderm PL System (K60772)

Submission Summary (Full Text)

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## Attachment I 510(K) Summary ProLite Pulsed Light System

## JAN 8 2002

K013365

This 510(K) Summary of safety and effectiveness for the ProLite VL 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.

> Lona Knapes gata 5 421 32 Vastra Frolunda,

Morgan Gustafsson

46.31.709.30.70 - Phone

ProLite Pulsed Light System

Intense Pulsed Light System

79-GEX, 21 CFR 878-48

Photoderm PL System

houses the waveguide

K number K60772

Instrument, Surgical, Powered, laser

46,31.709.30.79 - Fax [e-mail]

October 5, 2001

Sweden

Applicant:

Medical Bio Care Sweden AB.

Address:

Contact Person:

Telephone / Fax / Email

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Legally Marketed Predicate Device:

Description of the ProLite V Pulsed Light System

Intended use of the ProLite V Pulsed Light System

Performance Data:

Conclusion:

None The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of benign pigmented lesions and

the removal of tattoos in Dermatology and Plastic Surgery.

The ProLite Pulsed Light System delivers pulsed light at a

wavelength of 550 nanometers. The device consists of three

The ProLite Pulsed Light System is indicated the treatment

of benign pigmented lesions and the removal of tattoos.

interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the outer edge of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 8 2002

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

Re: K013365

Trade/Device Name: ProLite Pulsed Light System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 1, 2001 Received: October 10, 2001

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 (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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Stupt Rhodes

Colie M. Witten, Ph.D., M.D.

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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Koj3365//A'

## INDICATION FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: ProLite Pulsed Light System______________________________________________________________________________________________________________________________________

Indications for Use:

The ProLite Pulsed Light System is intended for the treatment of benign pigmented lesions and the removal of tattoos.

(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 Gener, Restorative and Neurological Devices | |
|--------------------------------------------------------|---------------------------------------------------------------------------------|----------------------|
| 510(k) Number | K013365 | |
| Prescription Use<br>(per 21 CFR 801.109) | OR | Over-the-Counter Use |