ARAMIS II DERMATOLOGICAL LASER

K032260 · Quantel Medical · GEX · Nov 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032260
• Device Name: ARAMIS II DERMATOLOGICAL LASER
• Applicant: Quantel Medical
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aramis II Dermatological Laser system is intended for the treatment of back acne.

Device Story

Aramis II Dermatological Laser is an Er:Glass laser system emitting coherent light at 1540 nm. The device delivers laser energy through a fiber optic cable to hand pieces, including a cooling hand piece, for dermatological procedures. Used in clinical settings by healthcare professionals, the device targets skin tissue to treat back acne. The cooling mechanism is integral to the delivery of the laser energy to the treatment site. The device is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on comparisons of specifications and characteristics.

Technological Characteristics

Er:Glass laser; 1540 nm wavelength; fiber optic delivery; includes cooling hand piece; Class II device (21 CFR 878.4810).

Indications for Use

Indicated for the treatment of back acne in patients requiring dermatological laser intervention.

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

• The Smoothbeam Laser System (K014128)

Submission Summary (Full Text)

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

K032260 1 of 2

ATTACHMENT #3

NOV 2 0 2003

## SECTION 9

## 510(k) SUMMARY

This 510(k) summary of safety and effectiveness for the ARAMIS II Dermatological Laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Quantel Medical |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | QUANTEL MEDICAL<br>21 rue Newton<br>ZI du BREZET<br>63039 Clermont-Ferrand<br>Cedex 2<br>FRANCE<br>[phone]<br>[phone] (Fax) |
| Contact Person: | Mr. Jean Abascal<br>([phone]<br>([phone] |
| Preparation Date:<br>(of the Summary) | July 2003 |
| Device Name: | ARAMIS II Dermatological Laser |
| Common Name: | Er:Glass Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (see: 21 CFR 878.4810).<br>Product Code: GEX<br>Panel: 79 |
| | Predicate devices: The Smoothbeam Laser System - K014128 |
| | Device description: The ARAMIS II Dermatological Laser emits a beam of coherent light at<br>1540 nms which is delivered to the hand pieces, including a cooling hand<br>piece, through a fiber optic. |
| Indications: | The ARAMIS II Dermatological Laser system, in addition to previously<br>cleared indications, is intended for the treatment of back acne. |

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

K032260 2 of 2

- Performance Data: None required; the ARAMIS II claims substantial equivalence to the Candela Smoothbeam based on comparisons of specifications/characteristics and indications for use
- CONCLUSION: Based on the information in this notification Quantel Medical concludes that the ARAMIS II, indicated for the treatment of back acne, is substantially equivalent to the Candela Smoothbeam.

rev. August 15, 2003

{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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, suggesting a sense of community and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Quantel Medical c/o Mr. Roger W. Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K032260

Trade/Device Name: Aramis II Dermatological Laser - New Indication 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: October 22, 2003 Received: October 28, 2003

Dear Mr. Barnes:

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.

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

Page 2 - Mr. Roger W. Barnes

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,

Muriam C. Provost

O 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

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

## SECTION 7

## INDICATIONS FOR USE STATEMENT

K032260 510(k) Number (if known):

Device Name: Aramis II Dermatological Laser - New indication

Indications for Use Statement:

The Aramis II Dermatological Laser system is intended for the treatment of back acne.

Miriam C. Provost

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

510(k) Number K032260

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ... Concurrence of CDRH, Office of Device Evaluation

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The Counter Use ________________________________________________________________________________________________________________________________________________________