VIKINI Diode Laser System
510(k) K151232
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151232 | Date6 Aug 2015 | StatusActive |
Official records
- FDA 510(k) database K151232
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Ilooda Co,., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
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.
Devices cleared under K151232
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VIKINI Laser H/P DET Laser H/P | DET Laser H/P | 08800023200225 | — | On the market |
| VIKINI Main Unit DET Main Unit | DET Main Unit / DET Main Unit | 08800023200218 | — | On the market |
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