American Medical Optics Monocular Indirect Ophthalmoscope

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

Full name

Amer. Medical Optics Monocular Indirect Ophthalmas

510(k) Number

K851264 ↗

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

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  FDA 510(k) K842127 Active Cleared 7 Sep 1984

• Amer. Medical Optic Monocular Direct Ophthalmascop

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  FDA 510(k) K851263 Active Cleared 1 May 1985

• Amer. Medical Optics Argon/Krypton Lase

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  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 Optics Monocular Indirect Ophthalmoscope used for?

  The AMO Monocular Indirect Ophthalmoscope is designed specifically for ophthalmic examinations, allowing clinicians to view the retina and other internal eye structures with greater detail than direct ophthalmoscopy. Its indirect viewing system magnifies the image and provides a wider field of view, making it ideal for assessing conditions like diabetic retinopathy, macular degeneration, or retinal detachment. The AC-powered design ensures consistent performance during prolonged use.

• How is the AMO Monocular Indirect Ophthalmoscope supplied, and is it single-use or reusable?

  The device is supplied as a reusable ophthalmic instrument, intended for clinical use in settings like eye clinics or hospitals. Unlike single-use devices, it requires proper cleaning, disinfection, and maintenance between patients to prevent cross-contamination. The manufacturer provides guidelines for sterilization and care to ensure longevity and compliance with infection control protocols.

• Are there different models or sizes available for the AMO Monocular Indirect Ophthalmoscope?

  The device is listed under multiple registration numbers (e.g., 3009685433, 1000391004), which may correspond to variations in accessories, attachments, or configurations rather than distinct models. These variations could include different headpieces, lenses, or power adapters to accommodate varying clinical needs. For exact specifications, refer to the manufacturer’s documentation or contact their technical support.

• How should the AMO Monocular Indirect Ophthalmoscope be stored to maintain its functionality?

  To preserve the device’s performance, store it in a clean, dry environment away from direct sunlight or extreme temperatures. Keep the headpiece and lenses protected from dust or scratches using the provided case or cover. Regularly inspect for wear, and follow the manufacturer’s instructions for maintenance, including lubrication of moving parts and calibration checks if applicable. Proper storage extends the device’s lifespan and ensures reliable operation during examinations.

• What regulatory pathway does the AMO Monocular Indirect Ophthalmoscope follow?

  The device is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K851264), indicating it has been deemed substantially equivalent to a legally marketed predicate device. This classification means it undergoes rigorous review by the FDA’s Ophthalmic Advisory Committee (OP) to ensure safety and effectiveness. The product code HLI and regulation number 886.1570 further categorize it within the ophthalmic device framework.