The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Sidelaze Laser Beam Delivery Accessory For Cynosure 1440nm Wavelength Lasers.
| Device ID | K121127 |
| 510k Number | K121127 |
| Device Name: | SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Irina Kulinets |
| Correspondent | Irina Kulinets CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-13 |
| Decision Date | 2012-05-13 |
| Summary: | summary |