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Mentor Meridian Phacoemulsification System

by Mentor O & O, Inc.

510(k) K955245

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955245 Date12 Feb 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Mentor Meridian Phacoemulsification System is an ophthalmic device used for phacofragmentation, a procedure that emulsifies and removes the lens during cataract surgery. It is classified as a Class II medical device under FDA regulation 886.4670.

The system received FDA 510(k) clearance (K955245) on February 12, 1996, as substantially equivalent to a predicate device. It is manufactured by Mentor O & O, Inc. and is intended for use in ophthalmic surgical settings.

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Questions

AI-generated answers, 1 Oct 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 Meridian Phacoemulsification System used for?

    The Meridian Phacoemulsification System is used for phacofragmentation, a procedure that emulsifies and removes the lens during cataract surgery, in ophthalmic surgical settings.

  • Is the Meridian Phacoemulsification System a single-use or reusable device?

    The device data does not specify whether the Meridian Phacoemulsification System is single-use or reusable, but it is classified as a Class II medical device under FDA regulation 886.4670.

  • What regulatory clearance has the Meridian Phacoemulsification System received?

    The Meridian Phacoemulsification System received FDA 510(k) clearance (K955245) on February 12, 1996, as substantially equivalent to a predicate device.

  • Who manufactures the Meridian Phacoemulsification System?

    The Meridian Phacoemulsification System is manufactured by Mentor O & O, Inc.