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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 K972347
Device Name MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
Applicant
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Applicant Contact ANNE WORDEN
Correspondent
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/24/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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