The following data is part of a premarket notification filed by Boston Foundation For Sight with the FDA for Bostonsight Ic Corneal Lens, Bostonsight Ic Scleral Lens.
| Device ID | K153066 |
| 510k Number | K153066 |
| Device Name: | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Boston Foundation For Sight 464 Hillside Avenue, Suite 205 Needham, MA 02494 |
| Contact | Eugene Bonte |
| 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 | 2015-10-22 |
| Decision Date | 2016-02-09 |
| Summary: | summary |