Cleared Traditional

RxSight Insertion Device

K181401 · Rxsight, Inc. · Ophthalmic
Jul 2018
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K181401 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 July 26, 2018, 58 days after receiving the submission on May 29, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K181401 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2018
Decision Date July 26, 2018
Days to Decision 58 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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