# K231901: Hakon, Hakon Smart

- Pathway: 510(k) (Traditional)
- Applicant: Medical San Indústria DE Equipamentos Médicos Ltda.
- Decided: Sep 28, 2023 after 92 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: 16 generations back to K910422 (1992). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210663: Dermatological Diode Laser Systems, Beijing HuaCheng Taike Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
The Dermatological Diode Laser (Model: Hakon and Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.

Source page: https://510kreport.com/device/K231901
Methodology: https://510kreport.com/methodology