(210 days)
Cutting, shaving, contouring and resection of oral osseous tissues (bone)
Not Found
This submission for the DELight Dental Laser System (K032797) contains no information on acceptance criteria or a study proving device performance against such criteria.
The 510(k) Summary explicitly states:
- "Nonclinical Performance Data: None"
- "Clinical Performance Data: None"
Therefore, I cannot provide the requested information. The device was cleared based on substantial equivalence to predicate devices (WaterLase, Millennium dental laser system) without new performance data being submitted or reviewed.
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APR = 5 2004
510(k) Summary
Ko32797
| Submitter: | Hoya Conbio (formerly Continuum)47733 Fremont BlvdFremont, CA 94538 |
|---|---|
| Contact: | Tom HaneyVP Dental Products |
| Date Summary Prepared: | September 4, 2003 |
| Device Trade Name: | DELight dental laser system |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX |
| Equivalent Device(s): | WaterLase, Millennium dental laser system |
| Intended Use: | Cutting, shaving, contouring and resection of oral osseous tissues (bone). |
| Comparison: | The BioLase WaterLase, Millennium dental laser systems are equivalentin operating parameters, physical characteristics, and intended uses. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 5 2004
Mr. Thomas Haney Vice President, Dental Products Hoya Conbio 47733 Fremont Boulevard Fremont, California 94538
Re: K032797
Trade/Device Name: DELight Dental Laser System 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 Codc: GEX Dated: December 29, 20()3 Received: January 6, 2004
Dear Mr. Haney:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 l'ederal 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Thomas Haney
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark Wilkinson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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032797
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Indications for Use Statement
510(k) Number (if known): pending
Device Name:
DELight Dental Laser System
Indications for Use:
Cutting, shaving, contouring and resection of oral osseous tissues (bone)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
b. Mark H. Milliman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K032797
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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.