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AMO Profinesse III Ultrasonic Handpiece System

by Allergan Medical Optics

510(k) K951462

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK951462 Date15 Jun 1995ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1033-2022 FDA Class II initiated 6 Apr 2022

    Potential breach in the sterility barrier for tray ring covers.

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  • Withdrawn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, 21 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 AMO Profinesse III Ultrasonic Handpiece System is a unit used for phacofragmentation in ophthalmic procedures. It is classified as a Class II medical device under FDA regulation 886.4670.

The system received FDA 510(k) clearance (K951462) on June 15, 1995, and is substantially equivalent to a legally marketed device. It is manufactured by Allergan Medical Optics in Irvine, California, and is intended for use in ophthalmic surgical settings.

Other devices from Allergan Medical Optics

Questions

AI-generated answers, 21 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 AMO Profinesse III Ultrasonic Handpiece System used for?

    The AMO Profinesse III Ultrasonic Handpiece System is used for phacofragmentation in ophthalmic procedures, specifically to break up and remove cataracts during eye surgery using ultrasonic energy.

  • Who manufactures the AMO Profinesse III Ultrasonic Handpiece System and where is it made?

    The system is manufactured by Allergan Medical Optics in Irvine, California, United States, as indicated by the facility address and applicant information in the FDA 510(k) submission.

  • What regulatory pathway was used for the AMO Profinesse III Ultrasonic Handpiece System?

    The device received FDA 510(k) clearance under submission K951462, determined to be substantially equivalent to a legally marketed predicate device, following a traditional review process.

  • When was the AMO Profinesse III Ultrasonic Handpiece System cleared by the FDA?

    The AMO Profinesse III Ultrasonic Handpiece System received FDA 510(k) clearance on June 15, 1995, after the application was received on March 30, 1995.

  • What is the device classification and regulation number for the AMO Profinesse III Ultrasonic Handpiece System?

    The device is classified as a Class II medical device under FDA regulation 886.4670, which governs ultrasonic phacoemulsification systems used in ophthalmic surgery.