The following data is part of a premarket notification filed by Quanta System S.p.a. with the FDA for Discovery Pico, Discovery Pico Plus.
Device ID | K171945 |
510k Number | K171945 |
Device Name: | Discovery Pico, Discovery Pico Plus |
Classification | Powered Laser Surgical Instrument |
Applicant | Quanta System S.p.A. Via Acquedotto, 109 Samarate, IT 20826 |
Contact | Francesco Dell'antonio |
Correspondent | Francesco Dell'antonio Quanta System S.p.A. Via Acquedotto, 109 Samarate, IT 20826 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-28 |
Decision Date | 2017-07-28 |
Summary: | summary |