Cleared Traditional

WOODLYN STANDARD SLIT LAMP HSSL-ST (K841765) - FDA 510(k) Clearance

Class I Ophthalmic device.

K841765 · Woodlyn, Inc. · Ophthalmic device
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Aug 1984
Decision
102d
Days
Class 1
Risk

K841765 is an FDA 510(k) clearance for the WOODLYN STANDARD SLIT LAMP HSSL-ST. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Woodlyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 102 days - within the typical 510(k) review window.

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: 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 Woodlyn, Inc. devices

Submission Details

510(k) Number K841765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1984
Decision Date August 07, 1984
Days to Decision 102 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 110d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLQ Keratoscope, Ac-powered
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.