SOUNDSKIN PHOTOTHERAPY SYSTEM

K040103 · Bhc International, Ltd. · GEX · Jan 18, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K040103
• Device Name: SOUNDSKIN PHOTOTHERAPY SYSTEM
• Applicant: Bhc International, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.

Device Story

Soundskin Phototherapy System is a visible light source for dermatological treatment; specifically moderate inflammatory Acne Vulgaris. Device consists of a base unit containing power supply/electronic control, a three-part support arm, and a lamp housing. System emits red light (635 +/- 5nm) and blue light (435 +/- 5nm) for uniform illumination of treatment area. Operation is automated via mechanical relays; no software used. Treatment cycle: 10 minutes red light followed by 10 minutes blue light; automatic shut-off after 20 minutes. Operated by healthcare professionals in clinical settings. Output intensity is 2460 mW/sq cm. Device provides non-invasive phototherapy to assist in acne management.

Clinical Evidence

No clinical data provided in the document. The manufacturer states that clinical trials prove effectiveness is the same as the predicate device, but specific study results, sample sizes, or metrics are not included in the provided text.

Technological Characteristics

Visible light source; red light (635 +/- 5nm) and blue light (435 +/- 5nm). Output intensity 2460 mW/sq cm. System comprises base unit, support arm, and lamp housing. Control system uses mechanical relays for timing; no software. Power supply integrated into base unit. Standalone device.

Indications for Use

Indicated for patients with moderate inflammatory Acne Vulgaris.

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

• Lumenis Clearlight (K013623)

Submission Summary (Full Text)

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JAN 8 2005 k040103 1/2

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## 1 8 20BHC International Ltd.

Smart Peel"" Skin Exfoliation Technology

Derma - Light Coloured Light Therapy

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510(k) Summary of safety and Effectiveness for the Soundskin Phototherapy System

This 510(k) Summary of safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92

General Information 1.

Submitter

Contact Person

BHC International Ltd 18 Stapledon Road Orton Southgate Peterborough PE2 6TD United Kingdom

Michael Breen 400 Lathrop Avenue Suite 200 River Forest IL 60305 USA Tel: [phone] Fax: [phone]

Summary Preparation Date

Wednesday, 20 October 2004

2. Names

Device Name:

Classification Name

Soundskin Phototherapy System

Laser Instrument, Surgical Powered Product Code: GEX Panel: 79

3. Predicate Devices

> The Soundskin Phototherapy System is substantially equivalent to the Lumenis Clearlight (K013623)

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40103 2/2

# BHC International Ltd.

Smart Peel ™ Skin Exfoliation Technology

Derma - Light Coloured Light Therapy

Image /page/1/Picture/5 description: The image shows a black and white logo of a globe. The text "World Leaders of Innovative Technology" is written in a circular fashion around the top of the globe. The text "Skin Resurfacing & Rejuvenation Equipment" is written in a circular fashion around the bottom of the globe. The globe itself is a wireframe design, with the continents shown in solid black.

#### 4. Device Description

The Soundskin Phototherapy System is a visible light source of high spectral purity, it provides uniform illumination of red light and blue light within the same lamp housing. The output is pre-tuned to one wavelength for each light, with a narrow spectral handwidth of 635 +/-5nm for red light and an output of 435 +/- 5nm bandwidth for blue light. The light output is 2460 mW ner sa cm of the treatment area with a lamp efficiency of 95% of the nutput. This compares with laser outputs which are approximately 2300-2500 mW per sq cm of area covered when measured in joules the output can average between 15 and 600 per sq cm. We have supplied technical data sheets and charts for the information requested.

The Soundskin system is in three parts, the hase unit contains the power supply and electronic control unit, the programme is electronic timed through mechanical relays instead of software for simplicity und reliability. The red light runs for 10 minutes then changes to blue light for 10 minutes, at the end of the 20 minute cycle it automatically shuts off. There is a separate mains supply switch attached to the base unit and a single on off switch on the lamp housing everything is uutomatic operation. A three part arm attached to the base unit supports the lamp housing, the head is attached to the end of the arm with a multifunctional positioning for natient treatment. The automatic controlled electronics operate from a single reset button on the lamp housing for easy access.

- న్ Indications for use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.

- Performance duta ().
Based upon an analysis of the overall performance characteristics for the Soundskin Light device, BHC. International believes that no significant differences exist hetween this system and the predicate system quoted. Therefore, the Soundskin Phototherapy System raises no new issues of safety and the clinical trials prove the effectiveness is the same.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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JAN 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BHC International Ltd. c/o Mr. Michael Breen 400 Lathrop Avenue, Suite 200 River Forest, Illinois 60305

Re: K040103 Trade/Device Name: Soundskin Phototherapy 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: December 21, 2004 Received: December 22, 2004

Dear Mr. Breen:

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 may or babyer to de 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 – Mr. Michael Breen

This letter will allow you to begin marketing your device as described in your Section 510(k) I ma letter will and 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/industry/support/index.html.

Sincerely yours,

Muriam C. Provost

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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## Indications for Use

510(k) Number (if known)

K040103

Device Name

Soundskin Phototherapy System

Indications for use

The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.

Prescription Use X Yes AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

No

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUF ON ANOTHER I'AGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K040103