The following data is part of a premarket notification filed by Inolase 2002, Ltd. with the FDA for Serenity Psf (pneumatic Skin Flattening) System.
| Device ID | K062589 |
| 510k Number | K062589 |
| Device Name: | SERENITY PSF (PNEUMATIC SKIN FLATTENING) 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2006-11-30 |
| Summary: | summary |