Cleared Traditional

K945877 - WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945877 · Wells Johnson Co. · Ophthalmic device
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Mar 1995
Decision
91d
Days
Class 2
Risk

K945877 is an FDA 510(k) clearance for the WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT. Classified as Transilluminator, Ac-powered (product code HJM), Class II - Special Controls.

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1945 - 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 Wells Johnson Co. devices

Submission Details

510(k) Number K945877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date March 02, 1995
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJM Transilluminator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1945
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.