Cleared Traditional

K850432 - LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS- (FDA 510(k) Clearance)

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

K850432 · Cooper Lasersonics, Inc. · Anesthesiology device
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Feb 1985
Decision
11d
Days
Class 2
Risk

K850432 is an FDA 510(k) clearance for the LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS-. Classified as Laser, Neodymium:yag, Pulmonary Surgery (product code LLO), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on February 15, 1985 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4500 - the FDA anesthesiology and respiratory 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cooper Lasersonics, Inc. devices

Submission Details

510(k) Number K850432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date February 15, 1985
Days to Decision 11 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 139d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLO Laser, Neodymium:yag, Pulmonary Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
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 Anesthesiology devices follow this clearance model.