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VIKINI Diode Laser System

Ilooda Co,., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Ilooda Co,., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

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Cited in this 510(k)

Cited as predicate

2
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Device details

FDA 510(k) registration fields

K number
K151232
Device name
VIKINI Diode Laser System
Company
Ilooda Co,., Ltd.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-05-08
Decision date
2015-08-06
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalVascular treatmentPigment treatment
Primary application
Hair removal
Classification source
AI classified

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.

Intended 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.

Summary parsed at:2026-06-01 06:11:09 UTC

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Cited as predicate

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2 submissions cite K151232 as a predicate