• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K171992, SculpSure, by Cynosure, Inc.

FDA 510(k) K171992, SculpSure, by Cynosure, Inc.

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510(K) Number: K171992
Device Name: SculpSure
Manufacturer: Cynosure, Inc.
Device Classification Name: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Regulation Number: 878.5400
Classification Product Code: PKT
Date Received: 07/03/2017
Decision Date: 09/26/2017
Regulation Medical Specialty: General & Plastic Surgery

Total pages: 1,442
Fully redacted pages: 1,076
Content pages: 366
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