MEDART 620

K120573 · Medart A/S · GEX · Jun 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120573
• Device Name: MEDART 620
• Applicant: Medart A/S
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CO2 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties: The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of: - Skin resurfacing - Treatment of wrinkles and rhytids - Treatment of furrows - Soft tissue ablation

Device Story

MedArt 620 is a CO2 laser system for soft tissue ablation and coagulation. Operated by physicians in clinical settings for dermatology, plastic, and general surgery. Device delivers laser energy to target tissue; enables skin resurfacing and treatment of wrinkles, rhytids, and furrows. System provides precise tissue interaction; benefits patients through controlled ablation/coagulation. Not for hard tissue dental use; not evaluated for fractionated scanning.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

CO2 laser system; energy source: laser radiation; intended for soft tissue ablation and coagulation. Regulation: 21 CFR 878.4810 (Laser surgical instrument).

Indications for Use

Indicated for soft tissue ablation and coagulation in dermatology, plastic, and general surgery, including skin resurfacing and treatment of wrinkles, rhytids, and furrows. Contraindicated for hard tissue dental applications (enamel, dentin, fillings) and non-cleared indications. Not evaluated for fractionated scanning.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 3 2012

Medart A/S % Energist Limited Mr. Darren Thomas Group Clinical Development Director 2, Park Pavilions, Clos Llyn CWM, Enterprise Park Swansea United Kingdom SA6 8QY

Re: K120573

Trade/Device Name: MedArt 620 Laser Systam 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: May 15, 2012 Received: May 18, 2012

Dear Mr. Thomas:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 – Mr. Darren Thomas

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K120573

pgiofl

Device Name: MedArt 620 Laser System

Indications for Use:

## Dermatology, Plastic & General Surgery

The CO2 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties:

The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:

- Skin resurfacing I
- Treatment of wrinkles and rhytids .
- Treatment of furrows I
- Soft tissue ablation .

## Contraindications for MedArt® 620

The MedArt® 620 may not be used for hard tissue dental applications such as tooth enamel, dentin or fillings and other indications not cleared by the FDA.

The system has not been evaluated for safety and effectiveness as a fractionated scanner

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120573

Section 4

Confidential