Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K170183 |
Device Name |
Cetus system, Cetus probe |
Applicant |
A.R.C. Laser GmbH |
Bessemer St. 14 |
Nurnberg,
DE
90411
|
|
Applicant Contact |
Angela Thyzel |
Correspondent |
A.R.C. Laser GmbH |
Bessemer St. 14 |
Nurnberg,
DE
90411
|
|
Correspondent Contact |
Angela Thyzel |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 01/23/2017 |
Decision Date | 09/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|