The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Litho.
| Device ID | K163009 |
| 510k Number | K163009 |
| Device Name: | Litho |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System SpA VIA ACQUEDOTTO 109 Samarate (va), IT 21017 |
| Contact | Francesco Dell' Antonio |
| Correspondent | Francesco Dell' Antonio Quanta System SpA VIA ACQUEDOTTO 109 Samarate (va), IT 21017 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-28 |
| Decision Date | 2016-12-01 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LITHO 90821109 not registered Live/Pending |
KaJ Labs Foundation 2021-07-09 |
![]() LITHO 88236399 not registered Live/Pending |
Purple Tambourine Limited 2018-12-20 |