Cleared Traditional

K192926 - RxSight Insertion Device

K192926 is an FDA 510(k) clearance for RxSight Insertion Device, manufactured by Rxsight, Inc.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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

FDA 510(k) Submission Details - K192926

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 110d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

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 16
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K192926.
RxSight Insertion Device
K231466 · Rxsight, Inc. · Jun 2023
CLAREON MONARCH IV IOL Delivery System
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Bausch + Lomb PreVue Inserter for enVista Preloaded
K192005 · Bausch & Lomb, Inc. · Oct 2019
UNFOLDER Vitan Inserter
K191949 · Johnson & Johnson Surgical Vision, Inc. · Sep 2019
BL-Cart IOL Delivery Cartridge
K182965 · Ast Products, Inc. · Mar 2019