DEKA TORO

El.En S.P.A.

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K240752
Device name
DEKA TORO
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-03-19
Decision date
2024-05-16
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentHair removalSurgical cutting
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

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 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-lait 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 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

Intended 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.

Device Description

TORO device is a DEKA laser system with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration. The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in Q-switched mode, and Ti:Sapphire laser at 785 nm operating in the Picosecond pulse mode. The Q-switched laser at 1064 nm can also operate in Thermal mode, delivering pulses of hundreds of microseconds. The laser beam generated by the source is then optically coupled to the articulated arm with a handpiece plugged at its end and delivered to the Patient.

Summary parsed at:2026-06-01 05:28:01 UTC

Predicate devices

3

K240752 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K240752 as a predicate