The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Biosyag Medical System.
| Device ID | K080374 |
| 510k Number | K080374 |
| Device Name: | BIOSYAG MEDICAL SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOS S.R.L. 4235 E. BROADWAY Long Beach, CA 90803 |
| Contact | Alessandro Franchi |
| Correspondent | Alessandro Franchi BIOS S.R.L. 4235 E. BROADWAY Long Beach, CA 90803 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-12 |
| Decision Date | 2008-05-15 |
| Summary: | summary |