Cleared Traditional

RxSight Insertion Device

K192926 · Rxsight, Inc. · Ophthalmic
Jan 2020
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K192926 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 January 17, 2020, 93 days after receiving the submission on October 16, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K192926 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2019
Decision Date January 17, 2020
Days to Decision 93 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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