Cleared Traditional

K842128 - AMERICAN MEDICAL OPTICS PHOTOKERATO

K842128 is an FDA 510(k) clearance for AMERICAN MEDICAL OPTICS PHOTOKERATO, manufactured by American Medical Optics. The device is a Class 1 Ophthalmic device with product code HJA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K842128 · American Medical Optics · Ophthalmic device
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Aug 1984
Decision
70d
Days
Class 1
Risk

K842128 is an FDA 510(k) clearance for the AMERICAN MEDICAL OPTICS PHOTOKERATO. Classified as Photokeratoscope (product code HJA), Class I - General Controls.

Submitted by American Medical Optics (Walker, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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 American Medical Optics devices

FDA 510(k) Submission Details - K842128

510(k) Number K842128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1984
Decision Date August 07, 1984
Days to Decision 70 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

HJA Device Classification - Class 1, General Controls

Product Code HJA Photokeratoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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.