Erchonia CLX (Model # CFL)

The Erchonia CLX is a handheld, non-invasive aesthetic laser device indicated for reducing the appearance of submental (chin) fat. It emits green (520 nm) and violet (405 nm) low-level laser light to temporarily create pores in fat cells, allowing lipids to be released and naturally processed by the body without surgery or thermal damage.

The CLX contains two semiconductor laser diodes emitting 7.5 mW each at green and violet wavelengths, compared to the Emerald (16 mW, green only) and Violet ZERONA Z8 (23 mW, violet only). All three devices use identical line-generating optics technology and deliver similar total joules per treatment area (~13.5–14.4 J). The CLX requires fewer diodes and shorter treatment time (15 minutes) because it targets the smaller submental region rather than larger body areas.

IEC 60601-1 (General Safety), IEC 60601-1-6 (Usability), IEC 60601-1-11 (Home Use), IEC 60601-1-2 (EMC), IEC 60825-1 (Laser Safety), and FDA performance standards 21 CFR 1040.10 and 1040.11 for light-emitting products. Risk assessment followed ISO 14971.

The CLX shares the same intended use, core low-level laser technology, mechanism of action, energy source, and wavelengths with predicate devices Emerald (K192544) and Violet ZERONA Z8 (K243811). A clinical study of 30 subjects achieved an 86.67% responder rate with no adverse events, demonstrating safe and effective fat reduction in the submental area. Minor differences in power, diode count, and targeted anatomy are supported by this new clinical data and do not raise new safety or effectiveness concerns.