DEKA LOTUS

The DEKA LOTUS is an aesthetic medical device combining pulsed intense light (IPL) and radiofrequency (RF) handpieces. The 570nm and 500G IPL handpieces treat benign vascular and pigmented skin lesions including telangiectasia, port wine stains, and melasma. The RF handpiece delivers 1 MHz bipolar radiofrequency energy for noninvasive treatment of mild to moderate facial wrinkles and rhytides.

The 570nm handpiece emits 570–1200 nm light at up to 25 J/cm² fluence with a 20×17 mm spot size and 40 ms maximum pulse duration. The 500G handpiece emits dual-band light (500–670 nm and 870–1200 nm) at up to 80 J/cm² fluence. The RF handpiece delivers sinusoidal 1 MHz bipolar current through three-electrode applicators at up to 50 W output. The key modification from the predicate (K233473) is replacement of a 590 nm filter with a 570 nm filter in the IPL handpiece.

IEC 60601-2-57:2011 (safety and performance of light source equipment used in aesthetic dermatology) for the modified IPL handpiece.

The 570 nm modification represents a minor optical refinement within the same 570–1200 nm emission spectrum already cleared for the predicate device. The indications for use remain identical to the predicate Quanta Chrome (K202503): photocoagulation of benign vascular lesions and treatment of pigmented lesions. All other parameters—fluence, pulse duration, repetition rate, and spot size—are identical or similar. The 500G and RF handpieces are unchanged from the prior DEKA LOTUS predicate (K233473). The filtering change does not alter the fundamental mechanism of action or safety profile.