Cleared Traditional

K842504 - AMER. MEDICAL OPTICS DIGITAL KERATO- (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K842504 · American Medical Optics · Ophthalmic device
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Oct 1984
Decision
97d
Days
Class 3
Risk

K842504 is an FDA 510(k) clearance for the AMER. MEDICAL OPTICS DIGITAL KERATO-. Classified as Intraocular Lens (product code HQL), Class III - Premarket Approval.

Submitted by American Medical Optics (Walker, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3600 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K842504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date October 01, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQL Intraocular Lens
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 886.3600
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.