The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Discovery Pico Family.
Device ID | K163222 |
510k Number | K163222 |
Device Name: | Discovery Pico Family |
Classification | Powered Laser Surgical Instrument |
Applicant | Quanta System Spa via Acquedotto, 109 Samarate, IT 21017 |
Contact | Francesco Dell'antonio |
Correspondent | Francesco Dell'antonio Quanta System Spa via Acquedotto, 109 Samarate, 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 | 2016-11-16 |
Decision Date | 2016-12-05 |
Summary: | summary |