Cleared Traditional

K820732 - LA VEL LATERAL VIEW EXTENSION LENS

K820732 is an FDA 510(k) clearance for LA VEL LATERAL VIEW EXTENSION LENS, manufactured by Peter M. Tolliver. The device is a Class 1 Ophthalmic device with product code HOI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K820732 · Peter M. Tolliver · Ophthalmic device
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May 1982
Decision
47d
Days
Class 1
Risk

K820732 is an FDA 510(k) clearance for the LA VEL LATERAL VIEW EXTENSION LENS. Classified as Spectacle, Magnifying (product code HOI), Class I - General Controls.

Submitted by Peter M. Tolliver (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5840 - 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.

FDA 510(k) Submission Details - K820732

510(k) Number K820732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1982
Decision Date May 03, 1982
Days to Decision 47 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
63d faster than avg
Panel avg: 110d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

HOI Device Classification - Class 1, General Controls

Product Code HOI Spectacle, Magnifying
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5840
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.

K820732 · LA VEL LATERAL VIEW EXTENSION LENS
Download PDF Peter M. Tolliver