The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Smartlipo Multiwavelength Laser With 1440nm Wavelength.
| Device ID | K091537 |
| 510k Number | K091537 |
| Device Name: | CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Anthony Burns |
| Correspondent | Anthony Burns 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 | 2009-05-26 |
| Decision Date | 2009-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494100445 | K091537 | 000 |
| 00841494100438 | K091537 | 000 |
| 00841494100353 | K091537 | 000 |