MEDART 455 SCANNER SYSTEM

K984339 · Del Mar Technologies, Inc. · GEX · Feb 18, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984339
• Device Name: MEDART 455 SCANNER SYSTEM
• Applicant: Del Mar Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedArt® 455/910-series Scanner will be used to manipulate and place a pulsed beam of laser energy in dermatology for treatment of ablation, vaporization or coagulation of soft tissue.

Device Story

MedArt 455/910-series Scanner is a laser delivery accessory used in dermatology. Device manipulates and positions pulsed laser beams to facilitate precise ablation, vaporization, or coagulation of soft tissue. Operated by clinicians in a medical setting, the scanner automates beam placement to improve surgical accuracy and control during dermatological procedures. By providing controlled energy delivery, the device assists the physician in achieving consistent tissue effects, potentially reducing procedure time and improving clinical outcomes for patients undergoing soft tissue treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laser beam delivery and manipulation system designed for dermatological soft tissue applications. Operates as an accessory to pulsed laser systems to control beam placement for ablation, vaporization, or coagulation.

Indications for Use

Indicated for use in dermatology for the ablation, vaporization, or coagulation of soft tissue via manipulation and placement of a pulsed laser beam.

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 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

Ms. Jan Enemaerke President Del Mar Technologies, Inc. 11772 Sorento Valley Road, Suite 237 San Diego, California 92121

K984339 Re:

Trade Name: MedArt® 455/910 Series Scanner Regulatory Class: II Product Code: GEX Dated: October 30, 1998 Received: December 4, 1998

Dear Ms. Enemaerke:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Ms. Jan Enemaerke

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K984339

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510(K) NUMBER (IF KNOWN):

MedArt® 455/910-series Scanner DEVICE NAME:

1NDICATIONS FOR USE:

The MedArt® 455/910-series Scanner will be used to manipulate and The MedAlto 4537920-senes occimer will bermatology for treatment place a pulsed bnofor of our of ablation, vaporization or coagulation of soft tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) |
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| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K984339 |

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