LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)

K983524 · Lares Research, Inc. · GEX · Apr 1, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983524
• Device Name: LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
• Applicant: Lares Research, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SunLase 800P is indicated for incising, excising and coagulating intraoral soft tissue, including the marginal and interdental gingiya. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

Device Story

SunLase 800P is a laser system designed for intraoral soft tissue surgery. Device functions by delivering laser energy to incise, excise, and coagulate soft tissue, including gingival epithelium and periodontal pockets. Operated by dental professionals in clinical settings. Output is laser energy used for surgical procedures; allows for precise tissue removal and coagulation. Benefits include controlled soft tissue management during periodontal procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laser system for intraoral soft tissue application. Product code GEX. Class II device.

Indications for Use

Indicated for incising, excising, and coagulating intraoral soft tissue, including marginal and interdental gingiva, epithelium lining, and sulcular debridement in patients requiring periodontal soft tissue management.

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

APR 1 1999

Mr. Thomas H. Louisell Director, Regulatory Affairs and Quality Systems Lares Research, Inc. 295 Lockheed Avenue Chico, California 95973

Re: K983524 Trade Name: Sunlase 800P Laser System Regulatory Class: II

Product Code; GEX Dated: January 8, 1999 Received: January 11, 1999

Dear Mr. Louisell:

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 Ouality 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. Thomas H. Louisell

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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## 510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________

DEVICE NAME : ________________________________________________________________________________________________________________________________________________________________ INDICATIONS FOR USE :

The SunLase 800P is indicated for incising, excising and coagulating intraoral soft tissue, including the marginal and interdental gingiya. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

Signature :

Thomas H. Jones

Name : Thomas H. Louisell Title : Director - Regulatory Affairs & Quality Systems Date : 29 March 1999

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983524

295 Lockheed Avenue . Chico, CA 95973 U.S.A. 800-347-3289 • Worldwide 530-345-1767 • Fax [phone] http://www.laresdental.com

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