Cleared Traditional

K872351 - FIBERLASE II ND:YAG LASER FOR PULMONARY USE (FDA 510(k) Clearance)

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

K872351 · Laser Media · Anesthesiology device
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Dec 1987
Decision
177d
Days
Class 2
Risk

K872351 is an FDA 510(k) clearance for the FIBERLASE II ND:YAG LASER FOR PULMONARY USE. Classified as Laser, Neodymium:yag, Pulmonary Surgery (product code LLO), Class II - Special Controls.

Submitted by Laser Media (Hauppauge, US). The FDA issued a Cleared decision on December 11, 1987 after a review of 177 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K872351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1987
Decision Date December 11, 1987
Days to Decision 177 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 139d · This submission: 177d
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.