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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 K103118
Device Name REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
Applicant
HOYA PHOTONICS, INC.
1105 SUNSET CREEK LANE
PLEASANTON,  CA  94566
Applicant Contact DONNA TEMPLEMAN
Correspondent
HOYA PHOTONICS, INC.
1105 SUNSET CREEK LANE
PLEASANTON,  CA  94566
Correspondent Contact DONNA TEMPLEMAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/21/2010
Decision Date 11/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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