MCL 30 DERMABLATE ER:YAG LASER SYSTEM

K042968 · Asclepion Laser Technologies GmbH · GEX · Nov 24, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042968
• Device Name: MCL 30 DERMABLATE ER:YAG LASER SYSTEM
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes). The smoke evacuator integrated into the handpiece is intended to remove aerosol, a by-product of laser treatment.

Device Story

MCL 30 Dermablate is an Er:YAG laser system (2.94 µm wavelength) used for soft tissue surgery. System includes articulated arm, handpiece, and integrated smoke evacuator for aerosol removal. Operated by physician via foot switch. Laser energy enables coagulation, vaporization, ablation, or cutting of skin. Used in dermatology, plastic surgery, oral surgery, and ophthalmology. Benefits include precise soft tissue management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Er:YAG laser system; 2.94 µm wavelength; 230 VAC, 16A, 50-60 Hz power; articulated arm and handpiece delivery; integrated smoke evacuation system; weight 85 kg; dimensions 970x360x650 cm.

Indications for Use

Indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

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

• DermaStar Er:YAG Laser System

Submission Summary (Full Text)

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NOV 2 4 2004

510(K) Summary

KO42967 Cynosure, Inc. Submitter: 10 Elizabeth Drive Chelmsford, MA 01824 George Cho Contact: Senior Vice President of Medical Technology October 25, 2004 Date Summary Prepared: MCL 30 Dermablate Er: Y AG Laser System Device Trade Name: MCL 30 Dermablate Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.48 Equivalent Device: DermaStar Er:Y AG Laser System MCL 30 Dermablate Er: Y AG Laser System is an Er: Y AG laser Device Description: system, having an articulated arm and handpiece. It is a laser with a wavelength of approximately 2.94 um. Laser emission activation is by foot switch. Overall weight of the laser is 85 kg, and the size is 970x360x650 cm (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. Smoke evacuation is provided by the evacuator integrated into the handpiece that removes the aerosol, a by-product of laser treatment. Intended Use: Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes). Comparison: The MCL 30 Dermablate Er: Y AG Laser System is substantially equivalent to the DermaStar Er: YAG Laser System, with the same principle of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses. Nonclinical Performance Data: none Clinical Performance Data: none Conclusion: The MCL 30 Dermablate Er: Y AG Laser System is another safe and effective device for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes). Additional Information: nonc

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Asclepion Laser Technologies GmbH c/o Mr. George Cho Senior Vice President, Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824

Re: K042968

Trade/Device Name: MCL 30 Dermablate Er: YAG Laser System 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 25, 2004 Received: October 28, 2004

Dear Mr. Cho:

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. George Cho

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,

Mark A. Millken

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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: MCL 30 Dermablate Er:Y AG Laser System

Indications For Use:

Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The smoke evacuator integrated into the handpiece is intended to remove aerosol, a by-product of laser treatment.

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millkeisen

al. Restorative, Division of Ge and Neurological Devices

510(k) Number K042968