The following data is part of a premarket notification filed by Canadian Pioneer Medical Technology Corporation with the FDA for Laser Treatment System , Models Nyx Plus, Grace Plus, Nemesis, Ares.
| Device ID | K211722 |
| 510k Number | K211722 |
| Device Name: | Laser Treatment System , Models Nyx Plus, Grace Plus, Nemesis, Ares |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Canadian Pioneer Medical Technology Corporation Unit 2 -210 Drumlin Circle, Concord Vaughan, CA L4k 3e3 |
| Contact | Rashid Reza Mir Reza Mir |
| Correspondent | Rashid Reza Mir Reza Mir 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 | 2021-06-04 |
| Decision Date | 2022-02-25 |