The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Sidelaze800 Laser Beam Delivery Accessory For Cynosure 1440mm Wavelength Lasers.
Device ID | K141511 |
510k Number | K141511 |
Device Name: | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS |
Classification | Powered Laser Surgical Instrument |
Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
Contact | Huda Yusuf |
Correspondent | Aastha Kohli CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-09 |
Decision Date | 2015-01-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841494100452 | K141511 | 000 |