Cleared Traditional

K801466 - LEIGH MEASURING SCALE #7725

K801466 is an FDA 510(k) clearance for LEIGH MEASURING SCALE #7725, manufactured by Edward Weck, Inc.. The device is a Class 1 Ophthalmic device with product code HLN cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801466 · Edward Weck, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1980
Decision
34d
Days
Class 1
Risk

K801466 is an FDA 510(k) clearance for the LEIGH MEASURING SCALE #7725. Classified as Gauge, Lens, Ophthalmic (product code HLN), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1420 - 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K801466

510(k) Number K801466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date July 28, 1980
Days to Decision 34 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
76d faster than avg
Panel avg: 110d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

HLN Device Classification - Class 1, General Controls

Product Code HLN Gauge, Lens, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1420
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.