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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K870517
Device Name 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE
Applicant
Coherent Medical Group
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Applicant Contact VIRGINIA SINGER
Correspondent
Coherent Medical Group
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Correspondent Contact VIRGINIA SINGER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/05/1987
Decision Date 04/10/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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