Cleared Traditional

RxSight Insertion Device (K181401) - FDA 510(k) Clearance

Class I Ophthalmic device.

K181401 · Rxsight, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
58d
Days
Class 1
Risk

K181401 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 July 26, 2018 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rxsight, Inc. devices

Submission Details

510(k) Number K181401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 110d · This submission: 58d
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 12
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K181401.
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