The following data is part of a premarket notification filed by Quanta System S.p.a. with the FDA for 2940 Nm Er:yag Laser Handpiece.
| Device ID | K173002 |
| 510k Number | K173002 |
| Device Name: | 2940 Nm Er:Yag Laser Handpiece |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System S.p.A. Via Acquedotto, 109 Samarate, IT 21017 |
| Contact | Francesco Dell’antonio |
| Correspondent | Francesco Dell’antonio Quanta System S.p.A. Via Acquedotto, 109 Samarate, IT 21017 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033945938321 | K173002 | 000 |
| 08033945938314 | K173002 | 000 |