Eneka Selectif

Termosalud

Country / region:Spain (ES)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Spain (ES)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241656
Device name
Eneka Selectif
Company
Termosalud
Country / region
Spain(ES)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-10
Decision date
2024-08-12
Submission type
Traditional
Technology type
Alexandrite(AI inferred)
Clinical applications
Hair removalPigment treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

ENEKA SELECTIF is intended for use in dermatologic and general surgical procedures. ENEKA SELECTIF System with 755nm Laser applicator is intended for:
- Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
- Treatment and prevention of Pseudofolliculitis barbae (PFB).
- Use on all skin types (Fitzpatrick I-VI).
- Treatment of benign pigmented lesions.
ENEKA SELECTIF System with 810nm Laser applicator is intended for:
- Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
- Treatment and prevention of Pseudofolliculitis barbae (PFB).
- Use on all skin types (Fitzpatrick I-VI).
- Treatment of benign pigmented lesions.
ENEKA SELECTIF System with 1060nm Laser applicator is intended for:
- Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
- Treatment and prevention of Pseudofolliculitis barbae (PFB).
- Use on all skin types (Fitzpatrick I-VI).
- Treatment of benign vascular lesions.
ENEKA SELECTIF System with 810 – 1060nm Laser applicator is intended for:
- Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.
- Treatment and prevention of Pseudofolliculitis barbae (PFB).
- Use on all skin types (Fitzpatrick I-VI).

Intended Use

ENEKA SELECTIF is intended for use in dermatologic and general surgical procedures. ENEKA SELECTIF System with 755nm Laser applicator is intended for: - Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign pigmented lesions. ENEKA SELECTIF System with 810nm Laser applicator is intended for: - Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign pigmented lesions. ENEKA SELECTIF System with 1060nm Laser applicator is intended for: - Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign vascular lesions. ENEKA SELECTIF System with 810 – 1060nm Laser applicator is intended for: - Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI).

Device Description

The ENEKA SELECTIF is a non-invasive diode laser system used for hair removal, prevention and treatment of Pseudofolliculitis barbae and treatment of vascular and pigmented lesions. The system operates at different wavelengths (755, 810 and 1060 nm) separately plus a blended handpiece combining three wavelengths (810, 940 and 1060 nm). The ENEKA SELECTIF is a diode laser device with 7 handpieces (spot sizes 10x9mm, 20x9mm and 30x12mm) and it allows two modes of treatment, DHR and FDHR. Both of them can be applied with every handpiece. Mode DHR allows the configuration of pulse width, frequency and fluency and mode FDHR allows the configuration of frequency and fluency.

Summary parsed at:2026-06-01 05:28:38 UTC

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2

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