DERMA K ER:YAG/CO2 LASER

K982827 · Esc Medical Systems, Inc. · GEX · Sep 14, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982827
• Device Name: DERMA K ER:YAG/CO2 LASER
• Applicant: Esc Medical Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Derma™ K Laser System is intended for incision, ablation, vaporization, and hemostasis of soft tissue.

Device Story

The Derma™ K Laser System is a surgical laser device used for soft tissue procedures. It functions by delivering laser energy to perform incision, ablation, vaporization, and hemostasis. Operated by physicians in clinical or surgical settings, the device provides precise tissue interaction to facilitate surgical outcomes. The system serves as a tool for surgeons to manage soft tissue during various medical interventions, potentially reducing bleeding and improving procedural efficiency through controlled thermal effects.

Technological Characteristics

Surgical laser system designed for soft tissue applications including incision, ablation, vaporization, and hemostasis. Operates via laser energy delivery. Specific materials, dimensions, and software details are not provided in the document.

Indications for Use

Indicated for incision, ablation, vaporization, and hemostasis of soft tissue in patients requiring surgical intervention.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol resembling an eagle or bird in flight, composed of three distinct, curved lines. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Mr. George J. Hattub Director, Clinical & Regulatory Affairs ESC Medical Systems, Inc. 250 First Avenue Needham, Massachusetts 02494

Re: K982827 Trade Name: Modified Derma™ Laser System Regulatory Class: II Product Code: GEX Dated: August 8, 1998 Received: August 11, 1998

## Dear Mr. Hattub:

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 - Mr. George J. Hattub

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,

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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510(k) Number (If known):

Device Name: Derma™ K Laser System

Indications For Use:

The Derma™ K Laser System is intended for incision, ablation, vaporization, and hemostasis of soft tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General Restorative Devices of 510(k) Number J

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)