PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR

K022568 · Medical Bio Care Sweden AB · GEX · Aug 29, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022568
• Device Name: PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
• 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 / Plasmalite MPX Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.

Device Story

ProLite / Plasmalite MPX Pulsed Light System delivers pulsed light starting at 600 nm wavelength for photoepilation. Device comprises cabinet (housing cooling system, power supply, microcontroller), umbilical, and handpiece (housing waveguide). Operated by clinical staff to treat unwanted hair. Light energy targets hair follicles to achieve hair removal. System uses internal microcontroller for operational control.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Pulsed light system; wavelength starting at 600 nm. Components: cabinet with cooling system, power supply, and microcontroller; umbilical; handpiece with waveguide. Energy source: electrical power supply. Control: microcontroller-based.

Indications for Use

Indicated for removal of unwanted hair in patients of all skin types (Fitzpatrick Scale).

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 / Plasmalite MPX Pulsed Light System (K013366)

Submission Summary (Full Text)

{0}------------------------------------------------

K022568/A'

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

AUG 2 9 2002

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 10, 2002 |
| Device Trade Name: | ProLite / Plasmalite MPX Pulsed Light System |
| Common Name: | Pulsed Light for Photoepilation |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | ProLite / Plasmalite MPX Pulsed Light System<br>K number K 013366 |
| Description of the ProLite / Plasmalite<br>MPX Pulsed Light System | The ProLite / Plasmalite MPX Pulsed Light System delivers<br>pulsed light at a wavelength beginning at a wavelength of<br>600 nm. The device consists of three interconnected<br>sections: The cabinet which houses the internal cooling<br>system, power supply and microcontroller, the umbilical to<br>the handpiece, and the handpiece, which houses the<br>waveguide |
| Intended use of the ProLite Pulsed Light<br>System | The ProLite / Plasmalite MPX Pulsed Light System is<br>indicated for use to remove unwanted hair in all skin types<br>according to the Fitzpatrick Scale. |
| 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 removal of unwanted<br>hair in all skin types according to the Fitzpatrick Scale. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three arms or wings extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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: K022568

Trade/Device Name: ProLite/Plasmalite MPX Pulsed Light System Regulation Number: 878.4810 Regulation Name: Instrument, surgical, powered, laser 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.

{2}------------------------------------------------

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 vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

{3}------------------------------------------------

## INDICATION FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: ProLite / Plasmalite MPX Pulsed Light System

ﻳ :

Indications for Use:

The ProLite Pulsed Light System is intended to remove unwanted hair for all skin types according to the Fitzpatrick Scale.

:

(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 | K022568 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <span></span> | OR | Over-the-Counter Use | <span></span> |
|----------------------|---------------|----|----------------------|---------------|
| (per 21 CFR 801.109) | | | | |