Cleared Special

K130866 - BIOLIGHT BIODYNAM (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130866 · Biolight AB · Physical Medicine device
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Oct 2013
Decision
211d
Days
Class 2
Risk

K130866 is an FDA 510(k) clearance for the BIOLIGHT BIODYNAM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Biolight AB (Stockholm, SE). The FDA issued a Cleared decision on October 25, 2013 after a review of 211 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biolight AB devices

Submission Details

510(k) Number K130866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date October 25, 2013
Days to Decision 211 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 115d · This submission: 211d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Peers - ILY Lamp, Infrared, Therapeutic Heating

All 228
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