ARAMIS DERMATLOGIC LASER

K012545 · Lumedics, Ltd. · GEX · Nov 5, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012545
• Device Name: ARAMIS DERMATLOGIC LASER
• Applicant: Lumedics, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aramis is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) and the treatment of benign pigmented lesions.

Device Story

Aramis Dermatologic Laser is an Er-glass 1.54 um laser system; includes laser unit, cooler, footswitch, and 2mm or 4mm handpiece. 4mm handpiece utilizes gas-cooling for skin protection. System parameters controlled via touch-buttons on laser unit interface. Used by clinicians for dermatological procedures; provides precise energy delivery for soft tissue management and vascular/pigmented lesion treatment. Benefits include controlled photothermolysis and coagulation, facilitating effective dermatological surgery.

Clinical Evidence

Bench testing only; device complies with 21 C.F.R. §§ 1040.10 and 1040.11, UL544, IEC 60-601-1, IEC 60-825-01, IEC 601-2-22, 93/42/EEC, and IEC 60-601-1-2.

Technological Characteristics

Er-glass 1.54 um laser system; 2mm or 4mm handpiece; gas-cooled handpiece; touch-button interface; electrical/laser safety per UL544, IEC 60-601-1, IEC 60-825-01, IEC 601-2-22, and IEC 60-601-1-2.

Indications for Use

Indicated for incision, excision, ablation, and coagulation of soft tissue; removal of pigmented lesions; and photocoagulation of dermatological vascular lesions, including facial and leg veins.

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

• Palomar Medical Technologies, Inc. Aramis Dermatologic Laser

Submission Summary (Full Text)

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Attachment 8

NOV 0 5 2001

#### 510(k) SUMMARY

K012545

# Lumedics's Aramis Dermatologic Laser

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Mitchell J. Robins Lumedics, Ltd. 7567 La Jolla Blvd. La Jolla, CA 92037 Phone: [phone] Facsimile: 858-551-1215

Mitchell J. Robins Contact Person:

August 6, 2001 Date Prepared:

# Name of Device and Name/Address of Sponsor

Lumedics Aramis Dermatologic Laser

Lumedics, Ltd. 7567 La Jolla Blvd. La Jolla, CA 92037

### Common or Usual Name

Dermatologic Laser

### Classification Name

Powered Laser Surgical Instrument for use in General Dermatological Use

#### Product Code

GEX Panel: 79

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### Predicate Devices

Palomar Medical Technologies, Inc. Aramis Dermatologic Laser

### Intended Use

The Aramis is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis Laser is also indicated for the photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins) and the treatment of benign pigmented lesions.

# Technological Characteristics and Substantial Equivalence

The Aramis Dermatologic Laser is an Er-glass 1.54 um system. The computer system consists of a laser unit, a cooler, a footswitch, and a 2mm or 4mm hand piece. The 4mm hand piece is gas-cooled to provide actual skin cooling. Laser parameters and other system features are controlled from the touch-buttons on top of the laser unit, which provides an interface to the system computer.

The Aramis is substantially equivalent to the currently marketed Palomar Aramis Dermatologic Laser powered surgical lasers in intended use, indications for use, principles of operation, and technological features. Any minor differences do not raise any new issues of safety or effectiveness.

### Performance Data

The Aramis complies with 21 C.F.R. §§ 1040.10 and 1040.11, as well as the following voluntary performance standards:

- UL544; Electrical Leakage ●
- IEC 60-601-1; Power Supply and Enclosure ●
- IEC 60-825-01; Safety of Laser Product .
- IEC 601-2-22; Therapeutic Laser Equipment Safety .
- 93/42/EEC: European Directive .
- IEC 60-601-1-2; Electromagnetic Compatibility .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an emblem that resembles an eagle or bird with three horizontal lines above it, possibly representing wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 5 2001

Lumedics, Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K012545

Trade/Device Name: Lumedics, Ltd. Aramis Dermatologic Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 6, 2001 Received: August 7, 2001

Dear Mr. Kahan:

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. Jonathan S. Kahan, Esq.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Susan Walkins

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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NOV 0 5 2001

Indications for Use Form

KD12545 510(k) Number (if known): __

Device Name: Lumedics, Ltd. Aramis Dermatologic Laser

Indications for Use:

The Aramis Dermatologic Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis 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).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative (Optional Format 1-2-96) Division of Neurological Devices

510(k) Number K012545