ARAMIS II DERMATOLOGICAL LASER

K023734 · Quantel Medical · GEX · May 6, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023734
• Device Name: ARAMIS II DERMATOLOGICAL LASER
• Applicant: Quantel Medical
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 6, 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 to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), and for the treatment of periorbital and perioral wrinkles. The Aramis II Dermatological Laser is also labeled: CAUTION: Federal law restricts the sale to or use by licensed professionals.

Device Story

Aramis II Dermatological Laser emits 1540 nm coherent light via fiber optic to hand pieces, including a cooling hand piece. Used by licensed professionals in clinical settings for soft tissue procedures, vascular lesion photocoagulation, and wrinkle treatment. Device utilizes pulse trains and epidermal cooling (to 5°C) to manage thermal effects, stimulate collagen synthesis, and promote fibroblastic proliferation while minimizing epidermal injury. Clinicians operate the device to deliver controlled fluence; patient outcomes include progressive skin remodeling and wrinkle reduction over several months. Cooling hand piece mitigates side effects like erythema and pain.

Clinical Evidence

Clinical evidence includes one pre-clinical study in hairless rats and three clinical studies involving 76 patients. Pre-clinical results showed new collagen synthesis and fibroblastic proliferation. Clinical studies evaluated dose-response and long-term outcomes (up to 14 months). Results demonstrated progressive improvement in skin texture and wrinkles with low incidence of complications (erythema, swelling, blistering). Biopsies confirmed significant collagen increases. Investigators recommended pulse train delivery and epidermal cooling to 5°C to optimize safety and efficacy.

Technological Characteristics

Er:Glass laser emitting 1540 nm coherent light. Features fiber optic delivery and integrated cooling hand piece. Operates via pulse train delivery. Designed for dermatological applications. No specific software algorithm class or connectivity details provided.

Indications for Use

Indicated for soft tissue incision, excision, ablation, and coagulation; removal of pigmented lesions; photocoagulation of dermatological vascular lesions (facial and leg veins); and treatment of periorbital and perioral wrinkles in patients requiring dermatological laser therapy. Restricted to use by licensed professionals.

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 Aramis laser (also Aramis I) (K012545 and K002649)
• The New Star Model 130 (K962791)
• The Smoothbeam Laser System (K013825)
• The CoolTouch and CoolTouch I (K003715)

Submission Summary (Full Text)

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## SECTION 10

510(k) SUMMARY

K023734

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 |
| : | ([phone]<br>([phone] |
| Preparation Date:<br>(of the Summary) | February 2003 (rev.) |
| Device Name: | Aramis II Dermatological Laser |
| Common Name: | Er:Glass Laser |
| Classification<br>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 Aramis laser (also Aramis I) - K012545 and K002649<br>The New Star Model 130 - K962791<br>The Smoothbeam Laser System - K013825<br>The CoolTouch and CoolTouch I - K003715 |
| Device description: | The Aramis II Dermatological Laser emits a beam of coherent light at 1540<br>microns which is delivered to the hand pieces, including a cooling hand<br>piece, through a fiber optic. |

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The Aramis II Dermatological Laser system is intended to be used for Indications: incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), and for the treatment of periorbital and perioral wrinkles.

> The Aramis Dermatological Laser is also labeled: "CAUTION: Federal law restricts the sale to or use by licensed professionals."

Performance Data: The results of pre-clinical and clinical studies were included.

A study of skin remodeling in hairless rats demonstrated that results are dose and temperature cooling dependent. Further, the thermal effects need to be controlled to reduce the risks of injury to the epidermis. Histological results showed new collagen synthesis and marked fibroblastic proliferation.

Three clinical studies in a total of 76 patients. All doses were administered in pulse trains and a cooling hand piece was used to cool the epidermis before treatment.

One clinical investigation was a dose-response study in 10 patients. The researchers reported some erythema, swelling, blistering, and crusting at higher doses. The researchers reported that lower doses should be administered to the periorbital area due to increased risk of side effects in this area.

Researchers in the other two clinical investigations reported results on 66 patients. In one study patients for followed for 6 months after the 3rd treatment; in the other they were followed for 14 months. The researchers reported there were no or only a low incidence of complications, such as pain, swelling, erythema, scabbing, or blisters. Both the periorbital and perioral areas were treated in these investigations.

Scheduled follow-ups in these two investigations, showed progressive improvement of the skin texture and the wrinkles. There were no unwanted side effects except for a brief erythema linked to the cooling. In one study biopsies were taken 6 months after the first treatment and showed significant increases in collagen.

The investigators suggested that the dose be administered as a train of pulses, that the skin should be cooled to 5℃, and that the fluence be controlled to avoid the critical temperature which leads to cell destruction.

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The investigators also suggested that patients be advised that the remodeling progresses slowly over several months and that they should not be disappointed by a lack of immediate effects.

Based on the information in this notification Quantel Medical concludes that CONCLUSION: the Aramis II, when intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) is substantially equivalent to cited legally marketed predicates.

> Quantel further concludes that the Aramis II intended the treatment of periorbital and perioral wrinkles skin remodeling, is safe and effective for these applications based on clinical studies and the ARAMIS II is substantially equivalent to cited legally marketed products.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

MAY 0 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023734

Trade/Device Name: ARAMIS II Dermatological Laser 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: February 10, 2003

Received: February 11, 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.

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Page 2 - Mr. Roger 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]. 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) you may obtain. 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,

Miriam 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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## SECTION 7

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K023734

Device Name: Aramis II Dermatological Laser

Indications for Use Statement:

The Aramis II Dermatological Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), and for the treatment of periorbital and perioral wrinkles.

The Aramis II Dermatological Laser is also labeled: CAUTION: Federal law restricts the sale to or use by licensed professionals.

uriam C. Provost

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

rev. 2/2003

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The Counter Use ________________________________________________________________________________________________________________________________________________________