Manufacturer
Kam Yuen Plastic Products , Ltd.Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
Kam Yuen Plastic Products , Ltd.
Country / Region:China (CN)Submission type:Traditional
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
- K230107
- Device name
- Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-01-13
- Decision date
- 2023-04-05
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- FaceBody
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Intended Use
Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device uses Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The hand-held device package includes main unit, adaptor and user manual and it uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
Summary parsed at:2026-06-11 04:38:32 UTC
Predicate devices
3Aimanfun Lumea Comfort
IPL Home Use Hair Removal Device
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Not ingested
K230107 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K230107 as a predicate