Cleared Special

RxSight Insertion Device (K231466) - FDA 510(k) Clearance

Class I Ophthalmic device.

K231466 · Rxsight, Inc. · Ophthalmic device
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Jun 2023
Decision
24d
Days
Class 1
Risk

K231466 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 June 12, 2023 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rxsight, Inc. devices

Submission Details

510(k) Number K231466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2023
Decision Date June 12, 2023
Days to Decision 24 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 12
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K231466.
EyeGility™ Inserter for Preloaded enVista IOLs
K242389 · Bausch & Lomb, Incorporated · Oct 2024
Accuject Refra Injector AR2900
K231106 · Medicel AG · Sep 2023
RxSight® Insertion Device (63002)
K231838 · Rxsight, Inc. · Aug 2023
CLAREON MONARCH IV IOL Delivery System
K212039 · Alcon Laboratories, Inc. · Aug 2021
bioli lOL Delivery System
K200057 · Ast Products, Inc. · Jun 2020
RxSight Insertion Device
K192926 · Rxsight, Inc. · Jan 2020