Device Classification Name |
Lens, Contact, Polymethylmethacrylate, Diagnostic
|
510(k) Number |
K201909 |
Device Name |
RxSight Contact Lens |
Applicant |
RxSight, Inc. |
100 Colombia |
Aliso Viejo,
CA
92656
|
|
Applicant Contact |
Maureen O'Connell |
Correspondent |
RxSight, Inc. |
100 Colombia |
Aliso Viejo,
CA
92656
|
|
Correspondent Contact |
Maureen O'Connell |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 07/09/2020 |
Decision Date | 09/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|