# K240752: Deka Toro

- Pathway: 510(k) (Traditional)
- Applicant: El.En S.P.A.
- Decided: May 16, 2024 after 58 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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). 318 ancestors in all.
No later device cites it as a predicate yet.
0 of 319 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 6.
- K213569: HOLLYWOOD SPECTRA Laser System, Lutronic Corporation (2022) Summary page 6.
- K230373: HELIOS 785 Pico, Laseroptek Co., Ltd. (2023) Summary page 6.

## Indications for use
785 nm laser source Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064 & 532 nm laser sources in Q-Switched, nanosecond mode Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to: 532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: • Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos • Treatment of benign vascular lesions including, but not limited to: – port wine birthmarks – telangiectasias – spider angioma – Cherry angioma – Spider nevi • Treatment of benign pigmented lesions including, but not limited to: – cafe-au-Iait birthmarks – Ephalides, solar lentigines – senile lentigines – Becker’s nevi – freckles – common nevi – nevus spilus – Ota Nevus • Treatment of seborrheic keratosis • Treatment of post inflammatory hyperpigmentation • Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: • Removal of dark ink (black, blue and brown) tattoos • Removal of benign pigmented lesions including; – nevus of Ota – Café au lait spot – Ephalides, solar lentigo (lentigines) – Becker Nevus – Nevus spilus • Treatment of common nevi • Removal or lightening of unwanted hair • Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064nm laser source in thermal mode (long-pulse) Intended for: • Treatment of wrinkles • Treatment of mild to moderate inflammatory acne vulgaris

Source page: https://510kreport.com/device/K240752
Methodology: https://510kreport.com/methodology