The following data is part of a premarket notification filed by I.t.s. Group S.r.l. with the FDA for Stardust Med.
| Device ID | K200736 |
| 510k Number | K200736 |
| Device Name: | Stardust Med |
| Classification | Powered Laser Surgical Instrument |
| Applicant | I.T.S. Group S.R.L. Via Del Cerchio, 1 Calderara Di Reno, IT 40012 |
| Contact | Claudio Bellina |
| Correspondent | Chiara Violini Endo Engineering SRL Via Del Consorzio, 41 Falconara Marittima, IT 60015 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-23 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056893740013 | K200736 | 000 |