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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K042165
Device Name CUTERA TABLETOP AESTHETIC PRODUCT
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD.
BRISBANE,  CA  94005
Applicant Contact KATHY MAYNOR
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received08/11/2004
Decision Date 10/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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