Cleared Traditional

RxSight Contact Lens

K201909 · Rxsight, Inc. · Ophthalmic
Sep 2020
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K201909 is an FDA 510(k) clearance for the RxSight Contact Lens, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Rxsight, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 10, 2020, 63 days after receiving the submission on July 9, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K201909 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2020
Decision Date September 10, 2020
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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