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 |