Cleared Traditional

K930937 - LD 400

K930937 is the FDA 510(k) clearance for LD 400 by Vismed, Inc.. It is a Class 1 Ophthalmic device (product code HPT) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K930937 · Vismed, Inc. · Ophthalmic device
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Oct 1993
Decision
237d
Days
Class 1
Risk

K930937 is an FDA 510(k) clearance for the LD 400. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Vismed, Inc. (San Diego, US). The FDA issued a Cleared decision on October 18, 1993 after a review of 237 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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 Vismed, Inc. devices

Submission Details

510(k) Number K930937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date October 18, 1993
Days to Decision 237 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 110d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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.

Regulatory Peers - HPT Perimeter, Automatic, Ac-powered

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