Cleared Traditional

K861583 - CO2 LASER BRONCHOSCOPE SYSTEM

K861583 is the FDA 510(k) clearance for CO2 LASER BRONCHOSCOPE SYSTEM by Richard Wolf Medical Instruments Corp.. It is a Class 2 Anesthesiology device (product code LLO) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K861583 · Richard Wolf Medical Instruments Corp. · Anesthesiology device
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May 1986
Decision
22d
Days
Class 2
Risk

K861583 is an FDA 510(k) clearance for the CO2 LASER BRONCHOSCOPE SYSTEM. Classified as Laser, Neodymium:yag, Pulmonary Surgery (product code LLO), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Rosemont, US). The FDA issued a Cleared decision on May 21, 1986 after a review of 22 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K861583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 21, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 140d · This submission: 22d
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.

Regulatory Peers - LLO Laser, Neodymium:yag, Pulmonary Surgery

All 7
Devices cleared under the same product code (LLO) and FDA review panel - the closest regulatory comparables to K861583.
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
K870505 · Trimedyne, Inc. · Aug 1987
6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION
K862698 · Cooper Lasersonics, Inc. · Aug 1986
LASER BRONCHOSCOPE SYSTEM
K861921 · Pilling Co. · Jun 1986
S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA
K855095 · Surgical Laser Technologies, Inc. · Feb 1986
LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS-
K850432 · Cooper Lasersonics, Inc. · Feb 1985