Ful-Vue

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K782118 ↗

FDA Product Code

HKN

Device Class

Class I

Regulation

21 CFR Part 886.1770

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Ao Stylet Laryngoscope Model Sls

  Class I

  FDA 510(k) K801364 Active Cleared 17 Jun 1980

• AORP4000 Reusable Pak

  Class II

  FDA 510(k) K931358 Active Cleared 22 Feb 1994

• Ultravue Blended Bifocal Lens

  Class I

  FDA 510(k) K791721 Active Cleared 23 Oct 1979

• Ao Flexible Laryngoscope, #ls-7

  Class I

  FDA 510(k) K802331 Active Cleared 10 Oct 1980

• Aoi Universal Ultrasonic Handpiece

  Class II

  FDA 510(k) K950880 Active Cleared 26 May 1995

• Model SC-6 Flexible Sigmoidoscope

  Class II

  FDA 510(k) K812965 Active Cleared 2 Nov 1981

See all devices from American Optical Corp. →