Cleared Special

RxSight Insertion Device

K231466 · Rxsight, Inc. · Ophthalmic
Jun 2023
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K231466 is an FDA 510(k) clearance for the RxSight Insertion Device, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Rxsight, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on June 12, 2023, 24 days after receiving the submission on May 19, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K231466 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2023
Decision Date June 12, 2023
Days to Decision 24 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MSS — Folders And Injectors, Intraocular Lens (iol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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