SPECTRAGENICS ATS-1

K060567 · Spectragenics, Inc. · GEX · Apr 28, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060567
• Device Name: SPECTRAGENICS ATS-1
• Applicant: Spectragenics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Device Story

SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device; emits light at a nominal wavelength of 410 nm. Device is intended for treatment of moderate inflammatory acne vulgaris. Operation involves direct application of light to affected skin areas. Device provides a non-invasive therapeutic option for patients; intended for dermatological use. Clinical efficacy and safety data support its use for the specified acne condition.

Clinical Evidence

Clinical data provided to demonstrate safety and efficacy for the treatment of moderate inflammatory acne vulgaris. Specific study metrics, sample sizes, and p-values were not detailed in the provided summary documentation.

Technological Characteristics

Handheld, electrically-powered light therapy device. Emits light at a nominal wavelength of 410 nm. Class II device under 21 CFR 878.4810 (Product Code GEX).

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris for the treatment of dermatological conditions.

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

• ClearLight Phototherapy System, Model CL420 (K013623)
• iClear Phototherapy System, Model FCGM0002 (K030338)
• Omnilux Blue (K030883)
• Palomar LuxV Handpiece (K040081)

Reference Devices

• Palomar StarLux Pulsed Light System (K041086)
• Radiancy Acne System with ClearTouch Light Unit Assembly (K051268)
• Radiancy Acne System with ClearTouch Light Unit Assembly (K032205)

Submission Summary (Full Text)

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

K 060567

## 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the SpectraGenics ATS-1 is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and follows the HHS Publication FDA 95-4158 concerning the content and organization of a 510(k) summary.

| Applicant: | SpectraGenics, Inc. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 5880 West Las Positas Blvd., Suite 52<br>Pleasanton, CA 94588-8522 |
| Contact person: | Robert E. Grove, Ph.D. |
| Telephone: | [phone] |
| Preparation date: | March 1, 2006 |
| Device Trade Name: | SpectraGenics ATS-1 |
| Common Name: | Light Therapy Device |
| Classification Name: | Laser Instrument, Surgical, Powered<br>(Laser surgical instrument for use in<br>general and plastic surgery and<br>dermatology)<br>Regulation No. 878.4810<br>Product Code: GEX; Panel: 79 |
| Legally Marketed Predicate Devices: | ClearLight Phototherapy System,<br>Model CL420<br>CureLight Ltd.<br>K013623<br><br>iClear Phototherapy System,<br>Model FCGM0002<br>K030338<br><br>Omnilux Blue<br>Photo Therapeutics, Ltd.<br>K030883<br><br>Palomar LuxV Handpiece<br>Palomar Medical Technologies, Inc.<br>K040081 |

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

Palomar StarLux Pulsed Light System Palomar Medical Technologies, Inc. K041086

Radiancy Acne System with ClearTouch Light Unit Assembly K051268, K032205

The SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm.

The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The specifications and indications for use of the SpectraGenics ATS-1 arc substantially equivalent to those claimed in one or more of the clearances for the above-listed predicate devices.

Clinical data is provided to demonstrate the safety and efficacy of the SpectraGenics ATS-1.

The SpectraGenics ATS-1 is substantially cquivalent to the legally-marketed claimed predicate devices for the purposes of this 510(k) submission.

## System Description:

Intended Use of the Device:

Performance Data:

Conclusion:

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SpectraGenics, Inc. c/o Robert E. Groves, Ph.D. President & CEO 5880 West Las Positas Boulevard - Suite 52 Pleasanton, California 94588-8522

APR 2 8 2006

Re: K060567

Trade/Device Name: SpectraGenics ATS-1 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: March 1, 2006 Received: March 10, 2006

Dear Dr. Groves:

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. Iisting 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

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

## Page 2 - Robert E. Groves, Ph.D.

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), 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/dsma/dsmamain.html

Sincerely yours.

Q. Malli

Mark N. Melke Director Division of General, Restorative

· and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

SpectraGenics ATS-1

66056

Indications For Use:

The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

eMee

(Division Sign Division of General, Restorative. and Neurological Devices

510(k) Number_ko60567

Page 1 of ____________________________________________________________________________________________________________________________________________________________________