# K241656: Eneka Selectif

- Pathway: 510(k) (Traditional)
- Applicant: Termosalud
- Decided: Aug 12, 2024 after 63 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: 25 generations back to K943450 (1995). 576 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 578 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201594: Primelase Excellence, High Technology Products S.L.U (2020) Summary page 6.

## Most influential descendants
- K253251: Leaseir MHR Xcell  (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) (2026), 0 descendants of its own

## Indications for use
Intended Use ENEKA SELECTIF is intended for use in dermatologic and general surgical procedures. Indications for Use 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)

Source page: https://510kreport.com/device/K241656
Methodology: https://510kreport.com/methodology