Cleared Traditional

K842410 - AMER. EDWARDS LAB FLEXISCOPE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K842410 · American Edwards Laboratories · Ophthalmic device
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Nov 1984
Decision
139d
Days
Class 1
Risk

K842410 is an FDA 510(k) clearance for the AMER. EDWARDS LAB FLEXISCOPE. Classified as Table, Instrument, Manual, Ophthalmic (product code HRK), Class I - General Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on November 5, 1984 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4855 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

Submission Details

510(k) Number K842410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date November 05, 1984
Days to Decision 139 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 110d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRK Table, Instrument, Manual, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4855
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.