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510(k) Data Aggregation
K Number
K233473Device Name
DEKA LOTUS
Manufacturer
El.EN S.p.A.
Date Cleared
2024-05-16
(204 days)
Product Code
ONF, GEI
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
El.EN S.p.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· The DEKA LOTUS 590nm pulsed light handpiece is indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benion pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Device Description
The DEKA Lotus is a device provided with two pulsed light handpieces and a RF handpiece. The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable. The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized. The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
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