# K151232: VIKINI Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ilooda Co,., Ltd.
- Decided: Aug 6, 2015 after 90 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K211637: Aroma Grand (2021), 0 descendants of its own

## Indications for use
The VIKINI DIODE LASER SYSTEM is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the 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 regimen.

Source page: https://510kreport.com/device/K151232
Methodology: https://510kreport.com/methodology