Cleared Traditional

CONTACT LENS LOUPE, INSPETION LOUPE (K852054) - FDA 510(k) Clearance

Class I Ophthalmic device.

K852054 · Ascon Medical Instruments, Ltd. · Ophthalmic device
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Sep 1985
Decision
119d
Days
Class 1
Risk

K852054 is an FDA 510(k) clearance for the CONTACT LENS LOUPE, INSPETION LOUPE. Classified as Gauge, Lens, Ophthalmic (product code HLN), Class I - General Controls.

Submitted by Ascon Medical Instruments, Ltd. (Westmont, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 119 days - within the typical 510(k) review window.

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: 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 Ascon Medical Instruments, Ltd. devices

Submission Details

510(k) Number K852054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date September 05, 1985
Days to Decision 119 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 110d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.