TempSure

Electrosurgical, Cutting & Coagulation & Accessories

Cynosure, Inc

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

Pre-market Notification Details

• Device ID: K190678
• 510k Number: K190678
• Device Name: TempSure
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: Cynosure, Inc 5 Carlisle Road Westford, MA 01886
• Contact: Michael King
• Correspondent: Michael King; Cynosure, Inc 5 Carlisle Road Westford, MA 01886
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-18
• Decision Date: 2019-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841494108431	K190678	000
00841494108434	K190678	000
00841494105105	K190678	000