Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
Shenzhen Ulike Smart Electronics Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Device details
FDA 510(k) registration fields
- K number
- K221002
- Device name
- IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-04-04
- Decision date
- 2022-06-01
- 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: UI04A, UI04B, UI04C), is an over-the-counter, home-use and single-person-use 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 is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). 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: UI04A, UI04B, UI04C have the same indication for use, performance, structure design and operation, the only difference is their enclosure color (UI04A is white, UI04B is mint green and UI04C is deep green).
Summary parsed at:2026-06-11 04:32:27 UTC
Predicate devices
3—
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Not ingested
IPL Hair Removal Device Joy Version
IPL Hair Removal
K221002 references 3 predicate/reference devices
Cited as predicate
9IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
IPL Home Use Hair Removal Device (SJ15)
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
9 submissions cite K221002 as a predicate
