BostonSight Scleral
Lens, Contact (other Material) - Daily
BostonSight
The following data is part of a premarket notification filed by Bostonsight with the FDA for Bostonsight Scleral.
Pre-market Notification Details
| Device ID | K183175 |
| 510k Number | K183175 |
| Device Name: | BostonSight Scleral |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | BostonSight 464 Hillside Avenue, Suite 205 Needham, MA 02494 |
| Contact | Gene Guselli |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2019-01-04 |
| Summary: | summary |
Trademark Results [BostonSight Scleral]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BOSTONSIGHT SCLERAL 87180978 5813922 Live/Registered |
The Boston Foundation for Sight, Inc. 2016-09-23 |
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