Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K162114 |
Device Name |
Photon, Photon Plus |
Applicant |
Zolar Technology & MFG Co. Inc. |
6315 Shawson Drive |
Mississauga,
CA
L5T 1J2
|
|
Applicant Contact |
Paul Atkins |
Correspondent |
Zolar Technology & MFG Co. Inc. |
6315 Shawson Drive |
Mississauga,
CA
L5T 1J2
|
|
Correspondent Contact |
Paul Atkins |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/29/2016 |
Decision Date | 12/12/2016 |
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
|