Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K220189 |
Device Name |
LISA Laser Surgical Fibers |
Applicant |
Omni-Guide Holdings, Inc. |
46 Manning Road |
Billerica,
MA
01821
|
|
Applicant Contact |
Carlos O Acosta |
Correspondent |
Omni-Guide Holdings, Inc. |
46 Manning Road |
Billerica,
MA
01821
|
|
Correspondent Contact |
Carlos O Acosta |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/24/2022 |
Decision Date | 04/29/2022 |
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
|