Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K180993 |
Device Name |
Beacon Advanced CO2 Laser System |
Applicant |
OmniGuide, Inc |
4 Maguire Road |
Lexington,
MA
02421
|
|
Applicant Contact |
Sam Wade |
Correspondent |
OmniGuide, Inc |
4 Maguire Road |
Lexington,
MA
02421
|
|
Correspondent Contact |
Sam Wade |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 04/16/2018 |
Decision Date | 06/28/2018 |
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
|