Cleared Traditional

K192926 - RxSight Insertion Device (FDA 510(k) Clearance)

Class I Ophthalmic device.

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

K192926 is an FDA 510(k) clearance for the RxSight Insertion Device. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Rxsight, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on January 17, 2020 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Rxsight, Inc. devices

Submission Details

510(k) Number K192926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 110d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 61
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K192926.
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K242389 · Bausch & Lomb, Incorporated · Oct 2024
Accuject Refra Injector AR2900
K231106 · Medicel AG · Sep 2023
RxSight® Insertion Device (63002)
K231838 · Rxsight, Inc. · Aug 2023
RxSight Insertion Device
K231466 · Rxsight, Inc. · Jun 2023
CLAREON MONARCH IV IOL Delivery System
K212039 · Alcon Laboratories, Inc. · Aug 2021