Cleared Traditional

K841765 - WOODLYN STANDARD SLIT LAMP HSSL-ST

K841765 is an FDA 510(k) clearance for WOODLYN STANDARD SLIT LAMP HSSL-ST, manufactured by Woodlyn, Inc.. The device is a Class 1 Ophthalmic device with product code HLQ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K841765

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 110d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

HLQ Device Classification - Class 1, General Controls

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.