Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K191685 |
Device Name |
PicoWay Laser System |
Applicant |
Candela Corporation |
530 Boston Post Road |
Wayland,
MA
01778
|
|
Applicant Contact |
Brenda Geary |
Correspondent |
Candela Corporation |
530 Boston Post Road |
Wayland,
MA
01778
|
|
Correspondent Contact |
Brenda Geary |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/24/2019 |
Decision Date | 09/16/2019 |
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
|