BostonSight® Specialty Lenses
FDA 510(k) clearance K241571 · decided 2024-08-14
Clearance details
- K-number
- K241571
- Device name
- BostonSight® Specialty Lenses
- Applicant
- Boston Foundation For Sight, Inc. D/B/A Bostonsight
- Decision
- Substantially Equivalent
- Date received
- 2024-05-31
- Decision date
- 2024-08-14
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.