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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 K170489
Device Name Skylit Phototherapy System
Applicant
Skylit Medical
4225 Executive Square, Suite 420
la jolla,  CA  92037
Applicant Contact martyn gross
Correspondent
Skylit Medical
401 North A Street
Suite 775
san diego,  CA  92101
Correspondent Contact don canal
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/17/2017
Decision Date 05/23/2017
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
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