American Medical Optical Binocular Indirect Ophthalmoscope

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

Full name

Amer. Medical Optical Binocular Indirect Ophthalma

510(k) Number

K851262 ↗

FDA Product Code

HLI

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• American Medical Optics I/a Kit- Irrig

  Class II

  FDA 510(k) K842197 Active Cleared 1 Oct 1984

• American Medical Optics Imaging Sys

  Class II

  FDA 510(k) K842127 Active Cleared 7 Sep 1984

• Amer. Medical Optic Monocular Direct Ophthalmascop

  Class II

  FDA 510(k) K851263 Active Cleared 1 May 1985

• Amer. Medical Optics Argon/Krypton Lase

  Class II

  FDA 510(k) K842250 Active Cleared 15 Aug 1984

• Medical Optics Phacoemulsification Kit

  Class II

  FDA 510(k) K844150 Active Cleared 11 Dec 1984

• Argon Laser Photocoagulator Sys

  Class II

  FDA 510(k) K843965 Active Cleared 6 Nov 1984

See all devices from American Medical Optics →

• What is the American Medical Optical Binocular Indirect Ophthalmoscope used for?

  This device is an ac-powered ophthalmoscope designed for indirect viewing of the eye during ophthalmic examinations. It allows clinicians to examine the retina and other structures of the eye that may not be visible with direct examination methods.

• How is the American Medical Optical Binocular Indirect Ophthalmoscope supplied?

  The device is supplied by American Medical Optics. The specific packaging, configuration, and any accessories included would be detailed in the product documentation provided by the manufacturer.

• What is the regulatory status of this ophthalmoscope?

  This device is regulated under FDA 510(k) clearance with product code HLI. It is classified as a Class II device with special controls, and the FDA issued a cleared decision on April 30, 1985, determining it to be substantially equivalent to other legally marketed devices.

• Is the American Medical Optical Binocular Indirect Ophthalmoscope reusable or single-use?

  The device data does not specify whether this particular model is designed for single-use or multiple uses. This information would be provided in the manufacturer's instructions for use, which should be consulted for proper handling and sterilization protocols.