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FDA 510(k), K171111, Sculpsure
FDA 510(k), K171111, Sculpsure
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510(K) Number: K171111
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: 04/14/2017
Decision Date: 06/13/2017
Regulation Medical Specialty: General & Plastic Surgery
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: 04/14/2017
Decision Date: 06/13/2017
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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