Cleared Traditional

K222484 - Retitrack (FDA 510(k) Clearance)

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

K222484 · C. Light Technologies, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
265d
Days
Class 2
Risk

K222484 is an FDA 510(k) clearance for the Retitrack. Classified as Monitor, Eye Movement (product code HLL), Class II - Special Controls.

Submitted by C. Light Technologies, Inc. (Medford, US). The FDA issued a Cleared decision on May 9, 2023 after a review of 265 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1510 - 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 C. Light Technologies, Inc. devices

Submission Details

510(k) Number K222484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2022
Decision Date May 09, 2023
Days to Decision 265 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
155d slower than avg
Panel avg: 110d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLL Monitor, Eye Movement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1510
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

Blur Product Development
Christy Coleman

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
NCT05222022 Completed Interventional Industry-sponsored

Engineering Evaluation of an Eye Movement Monitor Device

39
Patients (actual)
1
Site
Basic_science
Purpose
Open label
Masking
Condition studied Healthy
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Jacqueline Theis, OD
Sponsor C. Light Technologies, Inc. (industry)
Started 2022-02-18 → Primary completion 2023-05-31 → Completed 2023-10-10
Primary outcome
Device measurement of involuntary fixational microsaccade amplitude
Study completed - no results published. This trial concluded in 2023 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. Individual participant data will not be shared.
View full study on ClinicalTrials.gov