Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K191554 |
Device Name |
LightWalker Laser System Family |
Applicant |
Fotona d.o.o. |
Stegne 7 |
Ljubljana,
SI
1000
|
|
Applicant Contact |
Lina Rupnik |
Correspondent |
Fotona d.o.o. |
Stegne 7 |
Ljubljana,
SI
1000
|
|
Correspondent Contact |
Lina Rupnik |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/12/2019 |
Decision Date | 08/30/2019 |
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
|