Cleared Traditional

BostonSight? Specialty Lenses

K241571 · Boston Foundation For Sight, Inc. D/B/A Bostonsight · Ophthalmic
Aug 2024
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K241571 is an FDA 510(k) clearance for the BostonSight? Specialty Lenses, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Boston Foundation For Sight, Inc. D/B/A Bostonsight (Needham, US). The FDA issued a Cleared decision on August 14, 2024, 75 days after receiving the submission on May 31, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K241571 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2024
Decision Date August 14, 2024
Days to Decision 75 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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