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Amo Whitestar Signature Phacoemulsification System

by Abbott Medical Optics, Inc.

510(k) K111697

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 · Abbreviated NumberK111697 Date27 Sep 2011ClearedStatusActive

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  • Withdrawn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, 6 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 Amo Whitestar Signature Phacoemulsification System is a phacoemulsification system, which is a type of unit used for phacofragmentation. It is used in ophthalmic procedures.

The system is supplied as a modular device and is intended for use in anterior segment surgical procedures, such as cataract removal. It has been cleared by the FDA and has a product code of HQC, with a regulation number of 886.4670.

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Questions

AI-generated answers, 6 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 Amo Whitestar Signature Phacoemulsification System used for?

    The Amo Whitestar Signature Phacoemulsification System is used for cataract removal in ophthalmic procedures, specifically for anterior segment surgical procedures.

  • Is the Amo Whitestar Signature Phacoemulsification System supplied as a single unit or modular device?

    The system is supplied as a modular device, allowing for flexibility and customization in ophthalmic procedures.

  • What is the regulatory status of the Amo Whitestar Signature Phacoemulsification System?

    The Amo Whitestar Signature Phacoemulsification System has been cleared by the FDA, with a product code of HQC and regulation number of 886.4670.