Manufacturer
TermosaludEneka Selectif
Country / Region:Spain (ES)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
Predicate devices
2Primelase Excellence
Eneka Pro
K241656 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241656 as a predicate
