Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K212492 |
Device Name |
Frax 1940 for Nordlys and Frax Pro |
Applicant |
Candela Corporation |
251 Locke Drive |
Marlborough,
MA
01752
|
|
Applicant Contact |
Rina Ordonez |
Correspondent |
Candela Corporation |
251 Locke Drive |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Rina Ordonez |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/09/2021 |
Decision Date | 12/20/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04203745
|
Reviewed by Third Party |
No
|
Combination Product |
No
|