The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Elite + Laser System.
| Device ID | K141425 |
| 510k Number | K141425 |
| Device Name: | ELITE + LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Kelli Mcmillan |
| Correspondent | Kelli Mcmillan 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 | 2014-05-30 |
| Decision Date | 2014-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494103675 | K141425 | 000 |
| 00841494100070 | K141425 | 000 |
| 00841494100063 | K141425 | 000 |