Elfor-L

The Elfor-L is a cardiovascular blood flowmeter that non-invasively measures microvascular perfusion in skin and muscle tissue in humans using Miniaturized Dynamic Light Scattering (mDLS) technology. It is intended for clinical and preclinical research applications and consists of a sensor with laser light source and photodetectors, a control unit with microcontroller, and dedicated software for data processing.

The Elfor-L uses a VCSEL laser at 850nm wavelength (compared to predicate devices at 780-785nm), achieves perfusion accuracy of 250±10 PU, operates with a signal bandwidth of 5Hz-24kHz, and is powered by USB (5V; 0.5A) rather than standard wall power. It incorporates two photodetectors, an amplifier, current driver, A2D converter, and microprocessor—similar core components to the predicates but with miniaturized laser technology instead of fiber optic probes.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-4-2 (EMC), IEC 60825-1 (laser safety), ISO 10993-1 (biocompatibility including cytotoxicity, sensitization, and irritation testing), and FDA guidance for device software functions.

The Elfor-L has identical indications for use, same intended patient population (all ages), same body contact method (intact skin), and substantially equivalent performance specifications (perfusion range 0-2000 PU, accuracy ±10 PU, signal bandwidth overlap) as the predicate PeriFlux devices. Despite using newer VCSEL technology instead of fiber optics and USB power instead of wall power, these differences present no new safety or effectiveness concerns and the device meets the same regulatory classification, product code, and consensus standards.