(23 days)
• Tattoo Removal
• Treatment of Vascular Lesions
• Treatment of Pigmented Lesions
• Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
The MedliteTM C3 Q-Switched Nd:YAG Laser bases its design/construction from the integration of primary subsystems extracted from legally marketed predicate Continuum products. The new device performs and is specified within all product parameters of the predicate devices.
The provided 510(k) summary for the Medlite™ C3 Q-Switched Nd:YAG Laser explicitly states "None" for both "Nonclinical Performance Data" and "Clinical Performance Data".
Therefore, no information is available within this document to answer the requested questions regarding acceptance criteria and a study demonstrating the device meets those criteria. The device was found substantially equivalent to predicate devices based on its design/construction and performance within product parameters of those predicates, not on new performance data.
{0}------------------------------------------------
JUN 2 2 2001
510(k) Summary
| Submitter: | Continuum Electro-Optics, Inc.3150 Central expresswaySanta Clara, CA 95051 | K011677 |
|---|---|---|
| Contact: | Ronald Kohlhardt | |
| Date Summary Prepared: | December 15, 2000 | |
| Device Trade Name: | MedliteTM C3 Q-Switched Nd:YAG Laser | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laser79-GEX | |
| Equivalent Device(s): | MedliteTM Q-Switched Nd:YAG LaserMedliteTM IV Q-Switched Nd:YAG Laser | |
| Intended Use: | • Tattoo Removal• Treatment of Vascular Lesions• Treatment of Pigmented Lesions• Incision, Excision, Ablation, Vaporization of Soft Tissue forGeneral Dermatology | |
| Comparison: | The MedliteTM C3 Q-Switched Nd:YAG Laser bases itsdesign/construction from the integration of primary subsystemsextracted from legally marketed predicate Continuum products. Thenew device performs and is specified within all product parametersof the predicate devices. | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Additional Information: | None | 000123 |
:
{1}------------------------------------------------
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 that resembles an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
JUN 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald Kohlhardt Director, Regulatory Compliance and Quality Assurance Continuum Electro-Optics, Inc. 3150 Central Expressway Santa Clara, California 95051
Re: K011677
Trade/Device Name: Medlite™ C3 Q-Switched Nd: YAG Laser Regulation Number: 878.4810 Regulatory Class: II Product Code: GEX Dated: May 25, 2001 Received: May 30, 2001
Dear Mr. Kohlhardt:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave leviewed your becalled is ro(x) nearceantially equivalent (for the indications for use above and we nave doloriminou the arteted predicate devices marketed in interstate commerce stated in the encrosure) to legally markets of the Medical Device Amendments, or to devices that provision in the masterial 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 Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the rec. "The general onanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (soo aso very anto additional controls. Existing major regulations (1 chiaries rippt val), it they or casyon in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (QS) for Manufacturing Praction regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Drug result in regulatory action. In addition, FDA may publish comply with the GMT regarersing your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your promation in 11.642 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2 - Mr. Ronald Kohlhardt
This letter will allow you to begin marketing your device as described in your 510(k) premarket I ntification. The FDA finding of substantial equivalence of your device to a legally marketed preadicate 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) 594-4659. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Marlin N Milliken
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
{3}------------------------------------------------
Device Name:
Indications for Use:
Medlite™ C3 Q-Switched Nd: YAG Laser.
KO11677
Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
L. Mark N. Milliken
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011677
(Optional Format 1-2-96)
00:33
§ 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.