510(k) K241571
K241571 is an FDA 510(k) premarket notification submitted by Boston Foundation For Sight, Inc. D/B/A Bostonsight for the device "BostonSight® Specialty Lenses". The FDA issued a decision of Substantially Equivalent on August 14, 2024. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2024
- Date Received
- May 31, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type