# K250281: Deka Lotus

- Pathway: 510(k) (Special)
- Applicant: El.En S.P.A.
- Decided: Feb 26, 2025 after 26 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: 28 generations back to K943450 (1995). 405 ancestors in all.
No later device cites it as a predicate yet.
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.
- K233473: Deka Lotus, El.En S.P.A. (2024) Summary page 5.

## Indications for use
• The DEKA LOTUS 570nm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. • 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 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/K250281
Methodology: https://510kreport.com/methodology