# VIKINI Diode Laser System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/vikini-diode-laser-system-gex>
- Manufacturer: [Ilooda.co., Ltd](https://devicerts.com/manufacturers/ilooda-co-ltd) (South Korea, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: GEX

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Vikini Diode Laser System is a diode laser device classified under product code GEX, designed for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions. It operates by delivering controlled laser energy to target tissues, enabling precise and effective cosmetic and dermatological interventions in clinical settings.

This system is intended for use by trained healthcare professionals in regulated environments and has received FDA 510(k) clearance under the Traditional review pathway. It is supplied as a reusable medical device under the classification of Class 2, adhering to regulatory standards outlined in 21 CFR 878.4810. The device is manufactured by Ilooda Co., Ltd., based in South Korea.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K151232 · decision 2015-08-06 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K151232 [FDA 510(k)]
- FDA product code: GEX [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4810 [FDA 510(k)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: VIKINI Diode Laser System, Ilooda.co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/vikini-diode-laser-system-gex (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/vikini-diode-laser-system-gex.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/vikini-diode-laser-system-gex
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.