PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS

K022569 · Medical Bio Care Sweden AB · GEX · Aug 29, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022569
• Device Name: PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
• Applicant: Medical Bio Care Sweden AB
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProLite Pulsed Light System is intended to be used in the treatment of vascular lesions.

Device Story

The Prolite / Plasmalite MPX Pulsed Light System is a medical device designed for photothermolysis. It delivers pulsed light at a wavelength of 550 nanometers to treat vascular lesions. The system comprises three main components: a cabinet housing the power supply, cooling system, and microcontroller; an umbilical cord; and a handpiece containing the waveguide. The device is intended for use by healthcare professionals in clinical settings such as dermatology or plastic surgery offices. By delivering controlled light pulses, the device targets vascular structures to achieve therapeutic effects. The system is operated via a microcontroller-based interface.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed light system operating at 550 nm wavelength. Components include a power supply, cooling system, microcontroller, umbilical, and handpiece with waveguide. Class II device under 21 CFR 878.4810.

Indications for Use

Indicated for the treatment of vascular lesions 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

• ProLite Pulsed Light System (K010928)

Submission Summary (Full Text)

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DUPLICATE

K022569/A'

## AUG 2 9 2002

## Attachment I 510(K) Summary Prolite / Plasmalite MPX Pulsed Light System

This 510(K) Summary of safety and effectiveness for the Prolite / Plasmalite MPX 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: | Medical Bio Care AB |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Lona Knapes gata 5<br>421 32 Vastra Frolunda,<br>Sweden |
| Contact Person: | Morgan Gustafsson |
| Telephone / Fax / Email | 46.31.709.30.70 - Phone<br>46.31.709.30.79 - Fax<br>[e-mail] |
| Preparation Date: | August 11, 2002 |
| Device Trade Name: | Prolite / Plasmalite MPX Pulsed Light System |
| Common Name: | Pulsed Light for Photothermolysis |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | ProLite Pulsed Light System<br>K number 010928 |
| Description of the Prolite / Plasmalite<br>MPX Pulsed Light System | The Prolite / Plasmalite MPX Pulsed Light System delivers<br>pulsed light at a wavelength of 550 nanometers. The device<br>consists of three interconnected sections: The cabinet which<br>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 Prolite / Plasmalite<br>MPX Pulsed Light System | The Prolite / Plasmalite MPX Pulsed Light System is<br>indicated for the treatment of vascular lesions. |
| Performance Data: | None |
| Conclusion: | The ProLite / Plasmalite MPX Pulsed Light System is<br>substantially equivalent to other existing pulsed light<br>systems in commercial distribution for treatment of vascular<br>lesions in Dermatology and Plastic Surgery. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 9 2002

Medical Bio Care Sweden AB c/o Connie White Hoy 908 Stetson Street Woodland, California 95776

Re: K022569

Trade/Device Name: ProLite/Plasmalite MPX Pulsed Light System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 25, 2002

Received: August 2, 2002

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,

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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## INDICATION FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ K022569

Device Name: ProLite / Plasmalite MPX Pulsed Light System

Indications for Use:

The ProLite Pulsed Light System is intended to be used in the treatment of vascular lesions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (per 21 CFR 801.109)

OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Styt Plurde
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_KOZZS69