Cleared Traditional

SURGICAL MEDICAL DEVICE CAUTERY (K023506) - FDA 510(k) Clearance

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

K023506 · Modern Medical Equipment Mfg., Ltd. · Ophthalmic device
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Jan 2004
Decision
452d
Days
Class 2
Risk

K023506 is an FDA 510(k) clearance for the SURGICAL MEDICAL DEVICE CAUTERY. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Modern Medical Equipment Mfg., Ltd. (Richmond, US). The FDA issued a Cleared decision on January 13, 2004 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Modern Medical Equipment Mfg., Ltd. devices

Submission Details

510(k) Number K023506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2002
Decision Date January 13, 2004
Days to Decision 452 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
342d slower than avg
Panel avg: 110d · This submission: 452d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQP Unit, Cautery, Thermal, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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.