The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Biosyag 50 Med.
| Device ID | K043521 |
| 510k Number | K043521 |
| Device Name: | BIOSYAG 50 MED |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOS S.R.L. 16 INDIAN SPRING DR Silver Spring, MD 20901 |
| Contact | Alessandro Franchi Onde |
| Correspondent | Alessandro Franchi Onde BIOS S.R.L. 16 INDIAN SPRING DR Silver Spring, MD 20901 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-03-24 |
| Summary: | summary |