The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Iluminage Skin Smoothing Laser.
| Device ID | K133473 |
| 510k Number | K133473 |
| Device Name: | ILUMINAGE SKIN SMOOTHING LASER |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Kevin O'connell |
| Correspondent | Kevin O'connell CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-01-15 |
| Summary: | summary |