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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name over-the-counter powered light based laser for acne
510(k) Number K111286
Device Name QUASAR CALYPSO
Applicant
SILVER BAY, LLC
1131 ANTHEM VIEW LANE
KNOXVILLE,  TN  37922
Applicant Contact ROBERT WAGNER
Correspondent
SILVER BAY, LLC
1131 ANTHEM VIEW LANE
KNOXVILLE,  TN  37922
Correspondent Contact ROBERT WAGNER
Regulation Number878.4810
Classification Product Code
OLP  
Date Received05/06/2011
Decision Date 01/18/2012
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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