Clearance Summary
BostonSight® Specialty Lenses received FDA 510(k) clearance under submission number K241571, sponsored by Boston Foundation For Sight, Inc. D/B/A Bostonsight. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2024-08-14.
- Submission: K241571
- Applicant / Sponsor: Boston Foundation For Sight, Inc. D/B/A Bostonsight
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 2024-08-14
Classification & Regulation
This clearance is catalogued under FDA product code HQD and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.