The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Apl Medical System.
| Device ID | K072344 |
| 510k Number | K072344 |
| Device Name: | APL MEDICAL SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOS S.R.L. VIA GUIDO ROSSA, 10/12 Vimodrone (milan), IT I-20090 |
| Contact | Aldo Casalino |
| Correspondent | Aldo Casalino BIOS S.R.L. VIA GUIDO ROSSA, 10/12 Vimodrone (milan), IT I-20090 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-21 |
| Decision Date | 2007-12-03 |
| Summary: | summary |