Cleared Traditional

LIGHT COAGULATOR LC 250 (K881334) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881334 · Nk-Optik GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
596d
Days
Class 2
Risk

K881334 is an FDA 510(k) clearance for the LIGHT COAGULATOR LC 250. Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Nk-Optik GmbH (Munich D8000, DE). The FDA issued a Cleared decision on November 16, 1989 after a review of 596 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 General & Plastic Surgery submissions.

View all Nk-Optik GmbH devices

Submission Details

510(k) Number K881334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1988
Decision Date November 16, 1989
Days to Decision 596 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
481d slower than avg
Panel avg: 115d · This submission: 596d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAM Apparatus, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 General & Plastic Surgery devices follow this clearance model.