Cleared Traditional

BOSS?

K223700 · Intelon Optics, Inc. · Ophthalmic
Aug 2024
Decision
613d
Days
Class 2
Risk

About This 510(k) Submission

K223700 is an FDA 510(k) clearance for the BOSS?, a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Intelon Optics, Inc. (Woburn, US). The FDA issued a Cleared decision on August 16, 2024, 613 days after receiving the submission on December 12, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K223700 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2022
Decision Date August 16, 2024
Days to Decision 613 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MXK — Device, Analysis, Anterior Segment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850