Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
Shenzhen Ulike Smart Electronics Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Device details
FDA 510(k) registration fields
- K number
- K230122
- Device name
- IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-01-17
- Decision date
- 2023-04-10
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Hair Removal Device is indicated for the removal of unwanted 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
IPL Hair Removal Device is indicated for the removal of unwanted 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
IPL Hair Removal Device (Model: UI04 SD, UI04 DG), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and the spot size is 3.3cm2 that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience. IPL Hair Removal Device, model: UI04 SD, UI04 DG have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04 SD is Star White and UI04 DG is Dark Green).
Summary parsed at:2026-06-11 04:38:42 UTC
Predicate devices
3—
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Not ingested
IPL Hair Removal Device Joy Version
IPL Hair Removal
K230122 references 3 predicate/reference devices
Cited as predicate
9IPL Hair Removal Device (BE932C, BE932D, BE932E)
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
IPL Hair Removal Device (KCA511/KCA516/KCA522)
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
IPL Hair Removal Device (IPL-001, IPL-002)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
9 submissions cite K230122 as a predicate
