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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 K933007
Device Name SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS
Applicant
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact CHARLES ROSE
Correspondent
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact CHARLES ROSE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/21/1993
Decision Date 01/10/1994
Decision Substantially Equivalent (SESE)
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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