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ZeptoLink IOL Positioning System

by Centricity Vision, Inc.

510(k) K223763

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223763 Date11 Apr 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PUL
Device Class
Class II
Regulation
21 CFR Part 886.4100
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ZeptoLink IOL Positioning System is a surgical device classified as an intraocular lens (IOL) positioning tool, designed to assist in the precise placement of artificial lenses during cataract or refractive surgeries. It employs a non-invasive, contactless method to stabilize and align the IOL within the eye, reducing the risk of post-operative complications such as decentration or tilt.

This system is intended for single-use in sterile surgical settings, adhering to FDA 510(k) clearance under the Ophthalmic Advisory Committee. Supplied as a sterile, disposable device, it requires no special storage conditions beyond standard surgical instrument protocols. The device is regulated under Class II medical device classification and is approved for use in ophthalmic procedures, with no MRI safety restrictions noted.

Other devices from Centricity Vision, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ZeptoLink IOL Positioning System used for in cataract or refractive surgeries?

    The ZeptoLink IOL Positioning System is designed to assist surgeons in precisely placing artificial intraocular lenses (IOLs) during cataract or refractive surgeries. It uses a non-invasive, contactless method to stabilize and align the IOL within the eye, helping to minimize risks like decentration or tilt after surgery.

  • Is the ZeptoLink IOL Positioning System reusable or intended for single-use?

    The ZeptoLink IOL Positioning System is explicitly intended for single-use only in sterile surgical settings. This design ensures patient safety and hygiene, aligning with standard sterile instrument protocols in ophthalmic procedures.

  • What storage requirements does the ZeptoLink IOL Positioning System have?

    The device requires no special storage conditions beyond standard surgical instrument protocols. Since it is sterile and disposable, it should be stored in a clean, dry environment following manufacturer guidelines until use.

  • Does the ZeptoLink IOL Positioning System have any restrictions on use with MRI machines?

    The device does not have any noted MRI safety restrictions, meaning it can be safely used in procedures where MRI compatibility is not a concern. However, always verify compatibility with specific surgical protocols and equipment.

  • How was the ZeptoLink IOL Positioning System approved by the FDA?

    The ZeptoLink IOL Positioning System received FDA 510(k) clearance under the Ophthalmic Advisory Committee (OP) and was determined to be substantially equivalent to a predicate device. The clearance was granted on April 11, 2023, following a traditional review process.