(19 days)
The M2 Laser is indicated for hair removal application.
The M2 Laser is indicated for hair removal and benign vascular lesion removal applications.
The M2 Laser is a solid state laser, having the alexandrite crystal as the lasing medium. It is a pulsed laser with an invisible wavelength of 755nm and a non-contact handpiece. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.
The provided text states: "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
Therefore, no acceptance criteria, study details, or performance data are available in the provided document. The device was cleared based on substantial equivalence to a predicate device, the Cynosure Apogee Laser, without specific performance studies for this particular submission.
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JAN | 8 2000
1c994427
510(K) Summary
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | December 29, 1999 |
| Device Trade Name: | Cynosure M2 Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Apogee Laser |
| Device Description: | The M2 Laser is a solid state laser, having the alexandrite crystal asthe lasing medium. It is a pulsed laser with an invisible wavelength of755nm and a non-contact handpiece. |
| Laser activation is both by finger switch and footswitch. Overallweight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). | |
| Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase. | |
| Intended Use: | The M2 Laser is indicated for hair removal application. |
| Comparison: | The M2 Laser is substantially equivalent to the Cynosure ApogeeLaser. They are both solid state near infra-red lasers using alexandritecrystal as their lasing medium. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The M2 Laser is another safe and effective device for dermatologicalapplication, specifically hair removal. |
| Additional Information: | None |
:
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
K994427 Re:
Trade Name: Cynosure M2 Laser Regulatory Class: II Product Code: GEX Dated: December 29, 1999 Received: December 30,1999
Dear Mr. Cho:
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.
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
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Page 2 - Mr. George Cho
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.
Stupt Rhodes
James E. Dillard III Acting 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: _ Cynosure M2 Laser
Indications For Use:
The M2 Laser is indicated for hair removal and benign vascular lesion removal applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stut Rhodes
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994427
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.