The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Palomar Icon Aesthetic System.
| Device ID | K142376 |
| 510k Number | K142376 |
| Device Name: | Palomar Icon Aesthetic System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 Carlisle Road Westford, MA 01886 |
| Contact | Allyson Connor |
| Correspondent | Allyson Connor 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 | 2014-08-26 |
| Decision Date | 2014-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494102272 | K142376 | 000 |
| 00841494100520 | K142376 | 000 |
| 00841494103774 | K142376 | 000 |