Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K183175 |
Device Name |
BostonSight Scleral |
Applicant |
BostonSight |
464 Hillside Avenue, Suite 205 |
Needham,
MA
02494
|
|
Applicant Contact |
Gene Guselli |
Correspondent |
EyeReg Consulting, Inc. |
6119 Canter Ln |
West Linn,
OR
97068
|
|
Correspondent Contact |
Bret Andre |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 11/16/2018 |
Decision Date | 01/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|