The following data is part of a premarket notification filed by Inolase 2002, Ltd. with the FDA for Serenity Pro Psf System.
| Device ID | K071943 |
| 510k Number | K071943 |
| Device Name: | SERENITY PRO PSF SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INOLASE 2002, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub INOLASE 2002, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-13 |
| Decision Date | 2007-08-10 |
| Summary: | summary |