(175 days)
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).
Not Found
I apologize, but this document contains a letter from the FDA regarding a 510(k) clearance for the Sunlase 800P Laser System. It does not contain any information about acceptance criteria or a study proving device performance in the way you've outlined in your request (e.g., test sets, ground truth, expert qualifications, MRMC studies).
The document is a notification of substantial equivalence for a medical device, which means the device was found to be as safe and effective as a legally marketed predicate device. The 510(k) process typically doesn't involve the detailed performance study data you're asking for in this format, especially for devices cleared in 1999.
Therefore, I cannot fulfill your request with the provided input.
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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 530-345-1870 http://www.laresdental.com
- 67 JEW દર્યા તત્ત TO: わて
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.