Class Class II
BostonSight® Specialty Lenses (K241571)
Description
BostonSight® Specialty Lenses by Boston Foundation For Sight, Inc. D/B/A Bostonsight, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241571
Clearance Date2024-08-14
Clearance TypeTraditional
Product CodeHQD
Regulation Number886.5916
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241571
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BostonSight® Specialty Lenses (K241571) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | 2022 |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; ... | Bausch & Lomb, Incorporated | 2019 |
| K183175 | BostonSight Scleral | Bostonsight | 2019 |
| K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact ... | Contamac, Ltd. | 2018 |
Trace the full predicate network for K241571
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.