Cleared Traditional

K820535 - LASER GAS MIXTURES (FDA 510(k) Clearance)

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

K820535 · Union Carbide Corp. · Toxicology device
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Mar 1982
Decision
29d
Days
Class 2
Risk

K820535 is an FDA 510(k) clearance for the LASER GAS MIXTURES. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 874.4500 - the FDA toxicology 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 Union Carbide Corp. devices

Submission Details

510(k) Number K820535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date March 31, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWG Laser, Ent Microsurgical Carbon-dioxide
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 Toxicology devices follow this clearance model.