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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, ultraviolet, dermatological
510(k) Number K171702
Device Name Exciplex308nm
WTC2, 120 route des macarons
Valbonne,  FR 06 560
Applicant Contact Laurent Meilhac
AcKnowledge Regulatory Strategies, LLC
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number878.4630
Classification Product Code
Subsequent Product Code
Date Received06/08/2017
Decision Date 10/13/2017
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