PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR

K013366 · Medical Bio Care Sweden AB · GEX · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013366
• Device Name: PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
• 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 to remove unwanted hair for all skin types according to the Fitzpatrick Scale.

Device Story

ProLite Pulsed Light System delivers pulsed light (wavelengths starting at 600 nm) for photoepilation; targets melanin in human hair follicles via selective photothermolysis. Device comprises three sections: cabinet (housing internal cooling system, power supply, and microcontroller), umbilical, and handpiece (housing waveguide). Used in clinical settings by professionals for hair removal. Output is pulsed light energy; healthcare providers use device to achieve hair reduction. Benefits include effective hair removal without scarring.

Clinical Evidence

Clinical study conducted with observations recorded pre-treatment and 3-6 months post-treatment. Results demonstrated selective photothermolysis targeting melanin in hair follicles is effective for hair removal. No scarring reported in any subject. Performance data previously reported to FDA in 510(k) 010927.

Technological Characteristics

Pulsed light system; wavelength starting at 600 nm. Components: cabinet with internal cooling system, power supply, microcontroller, umbilical, and handpiece with waveguide. Energy source: electrical power supply. Class II device.

Indications for Use

Indicated for removal of unwanted hair in 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

• EpiLight / Photoderm HR System (K974536)

Submission Summary (Full Text)

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

## K613366

This 510(K) Summary of safety and effectiveness for the ProLite 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 Sweden 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: | September 22, 2001 |
| Device Trade Name: | ProLite 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: | EpiLight / Photoderm HR System<br>K number K974536 |
| Description of the ProLite Pulsed Light<br>System | The ProLite Pulsed Light System delivers pulsed light at a<br>wavelength beginning at a wavelength of 600 nm. The<br>device consists of three interconnected sections: The cabinet<br>which houses the internal cooling system, power sypply and<br>microcontroller, the umbilical to the handpiece, and the<br>handpiece, which houses the waveguide |
| Intended use of the ProLite Pulsed Light<br>System | The ProLite Pulsed Light System is indicated for use to<br>remove unwanted hair in all skin types according to the<br>Fitzpatrick Scale. |
| Performance Data: | Clinical studies were conducted to provide assurance that<br>difference in the specifications of the ProLite Pulsed Light<br>System and the predicate device for hair removal did not<br>result in different performance during use. These results<br>were previously reported to the FDA in 510(K) 010927. |

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

Observation in the clinical study were recorded prior to Results of Clinical Study: treatment and at 3-6 months after treatment. There was no scarring in any subject. The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal. The ProLite Pulsed Light System is substantially equivalent Conclusion: to other existing pulsed light systems in commercial distribution for removal of hair in Dermatology and Plastic Surgery.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

'JAN 0 8 2002

Re: K013366

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: September 22, 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,

Stept Rhodes
S. Colin McWhirter, 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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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,

Stepten Rhodes

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: ____ Pending _ KO1336b ________________________________________________________________________________________________________________________________________

Device Name: ProLite Pulsed Light System______________________________________________________________________________________________________________________________________

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 | K013366 |
|---------------|---------|
|---------------|---------|

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