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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 K201111
Device Name GentleMax Pro Plus
Applicant
Candela Corporation
251 Locke Dr
Marlborough,  MA  01752
Applicant Contact Yverre Bobay
Correspondent
Candela Corporation
251 Locke Dr
Marlborough,  MA  01752
Correspondent Contact Yverre Bobay
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/27/2020
Decision Date 05/26/2020
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
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