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 |