The following data is part of a premarket notification filed by Canadian Pioneer Medical Technology Corporation with the FDA for Laser Treatment System, Model: Nyx And Grace.
| Device ID | K210033 |
| 510k Number | K210033 |
| Device Name: | Laser Treatment System, Model: NYX And Grace |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Canadian Pioneer Medical Technology Corporation Unit 2 -210 Drumlin Circle, Concord Vaughan, CA L4k 3e3 |
| Contact | Rashid Reza Mirsayah |
| Correspondent | Rashid Reza Mir Sayah Canadian Pioneer Medical Technology Corporation Unit 2, 210 Drumlin Circle, Concord Vaughan, CA L4k 3e3 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-05 |
| Decision Date | 2021-02-26 |