Manufacturer
Ulike Co., Ltd.Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
Country / Region:Korea, Republic of (KR)Submission type:Special
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243030
- Device name
- Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
- Company
- Ulike Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-09-27
- Decision date
- 2024-10-25
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- FaceBody
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Intended Use
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
Diamond Air+, Model: UI04A, UI04B, UI04C, UI04M, UI04G, UI04W is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. The device uses IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The size of the device is about 60*38*169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the Diamond Air+ is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered to emit a pulse.
Summary parsed at:2026-06-11 04:48:33 UTC
Predicate devices
1Diamond Air+ (UI04A, UI04B, UI04C)
K243030 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K243030 as a predicate
