Cleared Traditional

K852054 - CONTACT LENS LOUPE, INSPETION LOUPE

K852054 is an FDA 510(k) clearance for CONTACT LENS LOUPE, manufactured by Ascon Medical Instruments, Ltd.. The device is a Class 1 Ophthalmic device with product code HLN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K852054 · Ascon Medical Instruments, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K852054

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.

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.