Device Classification Name |
photocoagulator and accessories
|
510(k) Number |
K182646 |
Device Name |
Vitreq disposable laser probes, light fibers and Chandelier |
Applicant |
Vitreq B.V. |
Segglant-Noord 2 |
Vierpolders,
NL
3237MG
|
|
Applicant Contact |
JanKees Wouts |
Correspondent |
Beaver-Visitec International, Inc. |
500 Totten Pond Rd - 10 CityPoint |
Waltham,
MA
02451
|
|
Correspondent Contact |
Genci Omari |
Regulation Number | 886.4690
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/24/2018 |
Decision Date | 05/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|