Sculpsure

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Cynosure, Inc

The following data is part of a premarket notification filed by Cynosure, Inc with the FDA for Sculpsure.

Pre-market Notification Details

• Device ID: K171992
• 510k Number: K171992
• Device Name: Sculpsure
• Classification: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
• Applicant: Cynosure, Inc 5 Carlisle Road Westford, MA 01886
• Contact: Amy Tannenbaum
• Correspondent: Amy Tannenbaum; Cynosure, Inc 5 Carlisle Road Westford, MA 01886
• Product Code: PKT
• CFR Regulation Number: 878.5400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-03
• Decision Date: 2017-09-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841494107994	K171992	000
00841494107963	K171992	000
00841494107956	K171992	000
00841494107468	K171992	000