Cleared Traditional

K223763 - ZeptoLink IOL Positioning System (FDA 510(k) Clearance)

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

K223763 · Centricity Vision, Inc. · Ophthalmic device
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Apr 2023
Decision
117d
Days
Class 2
Risk

K223763 is an FDA 510(k) clearance for the ZeptoLink IOL Positioning System. Classified as Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered (product code PUL), Class II - Special Controls.

Submitted by Centricity Vision, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 11, 2023 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - 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 Centricity Vision, Inc. devices

Submission Details

510(k) Number K223763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2022
Decision Date April 11, 2023
Days to Decision 117 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
7d slower than avg
Panel avg: 110d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
Definition Used To Perform Anterior Capsulotomy During Cataract Surgery
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.