Cleared Traditional

AMBLYOPIA TRAINER (K800112) - FDA 510(k) Clearance

Class I Ophthalmic device.

K800112 · Life-Tech Instruments, Inc. · Ophthalmic device
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Mar 1980
Decision
54d
Days
Class 1
Risk

K800112 is an FDA 510(k) clearance for the AMBLYOPIA TRAINER. Classified as Device, Fixation, Ac-powered, Ophthalmic (product code HPL), Class I - General Controls.

Submitted by Life-Tech Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1980 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1290 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life-Tech Instruments, Inc. devices

Submission Details

510(k) Number K800112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1980
Decision Date March 10, 1980
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPL Device, Fixation, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1290
Definition A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.)
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.