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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 K191086
Device Name Exciplex
Applicant
Clarteis
WTC2, 120 route des macarons
Valbonne,  FR 06560
Applicant Contact Laurent Meilhac
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Lucie Dalet
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/24/2019
Decision Date 12/11/2019
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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