The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Cyber Tm Family.
| Device ID | K131081 |
| 510k Number | K131081 |
| Device Name: | CYBER TM FAMILY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va), IT 21058 |
| Contact | Maurizio Bianchi |
| Correspondent | Maurizio Bianchi Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va), IT 21058 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-18 |
| Decision Date | 2013-07-03 |
| Summary: | summary |