Cleared Traditional

K221375 - CureSight-CS100 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K221375 · Novasight , Ltd. · Ophthalmic device
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Sep 2022
Decision
140d
Days
Class 2
Risk

K221375 is an FDA 510(k) clearance for the CureSight-CS100. Classified as Digital Therapy Device For Amblyopia (product code QQU), Class II - Special Controls.

Submitted by Novasight , Ltd. (Airport City, IL). The FDA issued a Cleared decision on September 29, 2022 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5500 - 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 Novasight , Ltd. devices

Submission Details

510(k) Number K221375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2022
Decision Date September 29, 2022
Days to Decision 140 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
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QQU Digital Therapy Device For Amblyopia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5500
Definition A Digital Therapy Device For Amblyopia Is A Device That Incorporates Dichoptic Presentations On Visual Displays Through Therapeutic Algorithms To Treat Amblyopia Or To Improve Visual Acuity Of Patients With Amblyopia.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Regulatory Pathways Group, Inc.
Lee Kramm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05185076 Unknown Interventional Industry-sponsored

Treatment for Amblyopia Under Binocular Conditions Versus the Standard of Care, Monocular Deprivation Treatment

A Prospective, Multicenter, Randomized, Masked, Controlled Pivotal Trial to Assess the Safety and Effectiveness of an Eye-Tracking-Based Treatment for Amblyopia Under Binocular Conditions Versus the Standard of Care, Monocular Deprivation Treatment (Occlusive Patching)

114
Patients (actual)
2
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Amblyopia
Study design Parallel
Eligibility All sexes · 4 Years+
Principal investigator Abraham Spierer, MD
Sponsor NovaSight (industry)
Started 2021-08-17 → Primary completion 2021-10-26 → Completed 2022-05-01
Primary outcome
best corrected visual acuity
View full study on ClinicalTrials.gov