Cleared Traditional

K212189 - FibroLux (FDA 510(k) Clearance)

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

K212189 · Multi Radiance Medical · Physical Medicine device
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Sep 2022
Decision
416d
Days
Class 2
Risk

K212189 is an FDA 510(k) clearance for the FibroLux. Classified as Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (product code NHN), Class II - Special Controls.

Submitted by Multi Radiance Medical (Solon, US). The FDA issued a Cleared decision on September 2, 2022 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Multi Radiance Medical devices

Submission Details

510(k) Number K212189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2021
Decision Date September 02, 2022
Days to Decision 416 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 115d · This submission: 416d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. This Device Emits Energy In The Infrared Or Other Wavelengths, Provides Non-heating And Non-thermal Effect, And Is Indicated For Adjunctive Use In Pain Therapy Or Related Indication. It Does Not Provide Therapeutic Topical Heating. The Classification Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use.
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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

All 52
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