Cleared Traditional

K201909 - RxSight Contact Lens (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K201909 is an FDA 510(k) clearance for the RxSight Contact Lens. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Rxsight, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 10, 2020 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - 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 K201909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.