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, Discovery Pico Derm.
| Device ID | K191842 |
| 510k Number | K191842 |
| Device Name: | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm |
| 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 | 2019-07-09 |
| Decision Date | 2019-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08059173392339 | K191842 | 000 |
| 08059173392322 | K191842 | 000 |
| 08059173392315 | K191842 | 000 |