Cleared Special

K130866 - BIOLIGHT BIODYNAM

K130866 is an FDA 510(k) clearance for BIOLIGHT BIODYNAM, manufactured by Biolight AB. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Special 510(k) pathway after a 211-day FDA review.

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.

FDA 510(k) Submission Details - K130866

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 116d · This submission: 211d
Pathway characteristics
Modification to existing cleared device.

ILY Device Classification - Class 2, Special Controls

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 215
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