The following data is part of a premarket notification filed by Canadian Pioneer Medical Technology Corporation (cpmt Laser) with the FDA for Alexandrite And Nd:yag Laser Models Canlase And Torlase.
| Device ID | K222673 |
| 510k Number | K222673 |
| Device Name: | Alexandrite And Nd:YAG Laser Models CANLASE And TORLASE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Canadian Pioneer Medical Technology Corporation (CPMT LASER) 210 Drumlin Circle, Concord Vaughan, CA L4K 3E3 |
| Contact | Rashid Reza Mir Sayah |
| Correspondent | Rashid Reza Mir Sayah Canadian Pioneer Medical Technology Corporation (CPMT LASER) 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 | 2022-09-06 |
| Decision Date | 2022-11-17 |