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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 K212492
Device Name Frax 1940 for Nordlys and Frax Pro
Applicant
Candela Corporation
251 Locke Drive
Marlborough,  MA  01752
Applicant Contact Rina Ordonez
Correspondent
Candela Corporation
251 Locke Drive
Marlborough,  MA  01752
Correspondent Contact Rina Ordonez
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/09/2021
Decision Date 12/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT04203745
Reviewed by Third Party No
Combination Product No
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