Boston Foundation For Sight
FDA Regulatory Profile
Boston Foundation For Sight appears in FDA public data with 2 recalls, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2191-2025, Class II) was initiated on June 10, 2025. Its most recent 510(k) clearance was granted on February 9, 2016.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2191-2025 | Class II | BostonSight PROSE Lens. | June 10, 2025 |
| Z-2190-2025 | Class II | BostonSight SCLERAL Lens | June 10, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | February 9, 2016 |