FDA 510(k) Application Details - K170489

Device Classification Name Light, Ultraviolet, Dermatological

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510(K) Number K170489
Device Name Light, Ultraviolet, Dermatological
Applicant Skylit Medical
4225 Executive Square, Suite 420
La Jolla, CA 92037 US
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Contact Martyn Gross
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Regulation Number 878.4630

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Classification Product Code FTC
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Date Received 02/17/2017
Decision Date 05/23/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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