Identifiers
- 510(k) Number
- K151232 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VIKINI Diode Laser System (K151232) — FDA 510(k) | Innolitics, VIKINI Diode Laser System, Products - Ilooda Co., Ltd., VIKINI 808nm Diode Hair Removal Laser | tradekorea
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151232 | Class II | Active |
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Manufacturer
- Manufacturer
- Ilooda.co., Ltd
- FDA Applicant
- Ilooda Co,., Ltd.
Sources (1)
- FDA 510(k) K151232 24 fields · synced Sep 19, 2026