Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K183452 |
Device Name |
Vbeam Prima Laser System |
Applicant |
Candela Corp. |
530 Boston Post Road |
Wayland,
MA
01778
|
|
Applicant Contact |
Sharon Timberlake |
Correspondent |
Candela Corp. |
530 Boston Post Road |
Wayland,
MA
01778
|
|
Correspondent Contact |
Sharon Timberlake |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/13/2018 |
Decision Date | 02/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|