Cleared Traditional

K811153 - COHERENT FLOUROTRON MASTER

K811153 is an FDA 510(k) clearance for COHERENT FLOUROTRON MASTER, manufactured by Lumenis, Inc.. The device is a Class 2 Chemistry device with product code HJO cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K811153 · Lumenis, Inc. · Chemistry device
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Jun 1981
Decision
50d
Days
Class 2
Risk

K811153 is an FDA 510(k) clearance for the COHERENT FLOUROTRON MASTER. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Lumenis, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 886.1850 - the FDA in vitro diagnostics and chemistry 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 Lumenis, Inc. devices

FDA 510(k) Submission Details - K811153

510(k) Number K811153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1981
Decision Date June 16, 1981
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 Chemistry devices follow this clearance model.