# K233473: Deka Lotus

- Pathway: 510(k) (Traditional)
- Applicant: El.En S.P.A.
- Decided: May 16, 2024 after 204 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K943450 (1995). 404 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 406 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202503: Chrome, Quanta System Spa (2020) Summary page 5.
- K110907: Palomar Icon (TM) Aesthetic System, Palomar Medical Technologies, Inc. (2011) Summary page 5.
- K173503: Pollogen Legend System, Pollogen, Ltd. (2018) Summary page 5.

## Most influential descendants
- K250281: Deka Lotus (2025), 0 descendants of its own

## Indications for 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 benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, angiomas, 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.

Source page: https://510kreport.com/device/K233473
Methodology: https://510kreport.com/methodology