Cleared Traditional

K252633 - UNITY DX (UDX) (FDA 510(k) Clearance)

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

K252633 · Cylite Pty. , Ltd. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Dec 2025
Decision
125d
Days
Class 2
Risk

K252633 is an FDA 510(k) clearance for the UNITY DX (UDX). Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Cylite Pty. , Ltd. (Mulgrave, AU). The FDA issued a Cleared decision on December 23, 2025 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Cylite Pty. , Ltd. devices

Submission Details

510(k) Number K252633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2025
Decision Date December 23, 2025
Days to Decision 125 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
15d slower than avg
Panel avg: 110d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
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

Alcon Research, LLC
Michelle Ravert

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
NCT06826599 Completed Observational Industry-sponsored

Agreement and Precision Study of UNITY® DX and a Comparator Biometer

160
Patients (actual)
1
Site
Condition studied Normal Eyes; Abnormal Eyes
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Arnold Ouyang, PhD
Sponsor Cylite Pty Ltd (industry)
Started 2025-01-18 → Primary completion 2025-03-30
Primary outcome
Central corneal thickness (CCT)
Secondary outcome
Anterior Chamber Depth Sum of Segments (ACD-SoS)
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 64
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K252633.
Tomey Cornea/Anterior Segment OCT (CASIA2)
K250553 · Tomey Corporation · Jul 2025
SPECTRALIS HRA+OCT and variants
K250868 · Heidelberg Engineering GmbH · May 2025
Anterion
K240924 · Heidelberg Engineering GmbH · Dec 2024
SPECTRALIS with Flex Module
K241163 · Heidelberg Engineering GmbH · Oct 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · Topcon Corporation · Jul 2024
SPECTRALIS HRA+OCT and variants
K240221 · Heidelberg Engineering GmbH · Jul 2024