# K223680: Eneka Pro

- Pathway: 510(k) (Traditional)
- Applicant: Termosalud
- Decided: Feb 10, 2023 after 64 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: 23 generations back to K943450 (1995). 527 ancestors in all.
No later device cites it as a predicate yet.
0 of 528 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191321: Primelase Excellence, High Technology Products S.L.U (2019) Summary page 4.

## Indications for use
Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include: • Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode 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 of Pseudofolliculitis barbae (PFB). • Use on all skin types (Fitzpatrick I-VI)

Source page: https://510kreport.com/device/K223680
Methodology: https://510kreport.com/methodology