Cleared Traditional

K223763 - ZeptoLink IOL Positioning System

K223763 is an FDA 510(k) clearance for ZeptoLink IOL Positioning System, manufactured by Centricity Vision, Inc.. The device is a Class 2 Ophthalmic device with product code PUL cleared through the Traditional 510(k) pathway after a 117-day FDA review.

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

FDA 510(k) Submission Details - K223763

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.

PUL Device Classification - Class 2, Special Controls

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.