Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K222673 |
Device Name |
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE |
Applicant |
Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
210 Drumlin Circle, Concord |
Vaughan,
CA
L4K 3E3
|
|
Applicant Contact |
Rashid Reza Mir Sayah |
Correspondent |
Canadian Pioneer Medical Technology Corporation (CPMT LASER) |
210 Drumlin Circle, Concord |
Vaughan,
CA
L4K 3E3
|
|
Correspondent Contact |
Rashid Reza Mir Sayah |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/06/2022 |
Decision Date | 11/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|