308 DERMATOLOGICAL EXCIMER SYSTEM

K073066 · Quantel Medical, Inc. · FTC · Dec 26, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K073066
• Device Name: 308 DERMATOLOGICAL EXCIMER SYSTEM
• Applicant: Quantel Medical, Inc.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Dec 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.

Device Story

The 308 Dermatological Excimer System is a xenon-chloride excimer lamp emitting 308 nm ultraviolet light for dermatological treatment. The device is computer-controlled and displays treatment parameters to the operator. It is used for the treatment of psoriasis and vitiligo. The system provides an output power of 800 mW ±10% over a 16 cm2 area. It is intended for professional use in a clinical setting.

Clinical Evidence

No clinical data. The manufacturer states that clinical tests are not necessary because the device uses the same technology as the predicate device. Evidence consists of bench testing, including output power and stability measurements, and software validation.

Technological Characteristics

Xenon-chloride excimer lamp; 308 nm wavelength; 800 mW ±10% output power; 16 cm2 treatment area. Computer-controlled interface. Tested to ISO 60601-1 (electrical safety) and ISO 60601-1-2 (electromagnetic compatibility).

Indications for Use

Indicated for patients with psoriasis and vitiligo.

Regulatory Classification

Identification

An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

Predicate Devices

• PhotoMedex VTRAC XL (K051428)

Submission Summary (Full Text)

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

K 073066

## Quantel Medical 510(k) 308 Dermatological Excimer System

## 510(k) Summary

(1) Submitter Information

Name: Quantel Medical

Address:

21 rue Newton - Zone du BREZET Clermont-Ferrand 63039 France

Telephone Number: 33-1-69-29-17-00

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: October 1, 2007

(2) Name of Device

Trade Name: 308 Excimer Lamp Phototherapy system Classification name: Ultraviolet Lamp for Dermatological Disorders

(3) Equivalent legally-marketed devices.

PhotoMedex VTRAC XL, K051428

(4) Description

The 308 is indicated for dermatological procedures for the treatment of psoriasis and vitiligo. The lamp is a xenon-chloride excimer lamp with a wavelength of 308 nanometers. Its output power is 800 mW ±10% for 2.48 ' ? (16 cm2). It is computer controlled, and displays the treatment parameters.

DEC 2 & 2007

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

(5) Intended Use

. The 308 system is intended to be used for the treatment of psoriasis and vitiligo.

(6) Performance Data

(a) Non-clinical tests

The 308 has been extensively validated, both the lamp itself and the software. It has been tested to ISO 60601-1 and ISO 60601-1-2. The lamp has been tested for output power and stability, and the software has been validated.

(b) Clinical tests

Clinical tests are not necessary, since the 308 uses the same technology as the predicate device.

(c) Conclusions

The 308 is equivalent in safety and efficacy to the legally-marketed predicate devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures, represented by curved lines, facing to the right.

Public Health Service

DEC 2 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Quantel Medical, Inc. % Medsys, Inc. Mr. George Myers 377 Route 17 Hasbrouck Heights, New Jersey 07604

Re: K073066

Trade/Device Name: Model 308 Dermatological Excimer System Regulatory Number: 21 CFR 878.4630 Regulatory Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: October 25, 2007 Received: October 30, 2007

Dear Mr. Myers:

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 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.

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

Page 2 - Mr. George Myers

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Quantel Medical 308

Page 4-1

Indications for Use 510(k) Number (if known): K 073066

Device Name: Model 308 Dermatological Excimer System

Indications For Use:

The Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.

Prescription Use Over-The-Counter Use AND/OR

(Part 21 CFR 801 Subpart D)

(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)

Barbara Buehrig

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

510(k) Number_KO 33066