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Amo Elite

by Allergan Medical Optics

510(k) K924235

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK924235 Date23 Dec 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0907-04 FDA Unclassified (pre-2012) initiated 29 Mar 2004

    The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.

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  • Withdrawn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

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