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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 K071469
Device Name INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
Applicant
CANDELA CORP.
530 BOSTON POST ROAD
WAYLAND,  MA  01778
Applicant Contact JEFFREY ROBERTS
Correspondent
CANDELA CORP.
530 BOSTON POST ROAD
WAYLAND,  MA  01778
Correspondent Contact JEFFREY ROBERTS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/29/2007
Decision Date 08/15/2007
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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