SculpSure

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Cynosure

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

Pre-market Notification Details

• Device ID: K182741
• 510k Number: K182741
• Device Name: SculpSure
• Classification: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
• Applicant: Cynosure 5 Carlisle Road Westford, MA 01886
• Contact: Amy Tannenbaum
• Correspondent: Amy Tannenbaum; Cynosure 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: 2018-09-28
• Decision Date: 2019-01-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841494107925	K182741	000