Cleared Traditional

RxSight? Insertion Device (63002)

K231838 · Rxsight, Inc. · Ophthalmic
Aug 2023
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K231838 is an FDA 510(k) clearance for the RxSight? Insertion Device (63002), 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 August 15, 2023, 54 days after receiving the submission on June 22, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K231838 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2023
Decision Date August 15, 2023
Days to Decision 54 days
Submission Type Traditional
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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