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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 K933318
Device Name COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
Applicant
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Applicant Contact VIRGINIA SINGER
Correspondent
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Correspondent Contact VIRGINIA SINGER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/19/1993
Decision Date 07/08/1994
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
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