Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
Shenzhen Ulike Smart Electronics Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K223618
- Device name
- IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-12-05
- Decision date
- 2023-02-28
- 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: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD), 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 sapphire 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: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD have the same indication for use, performance, structure design and operation, the only difference is their enclosure color (UI06 PL is Purple, UI06 PN is Pink, UI06 JL is Yellow, UI06 BR is Brown, UI06 DB is Dark Brown, UI06 PR is Dark Purple, UI06 OG is Maple Red, UI06 RD is Red).
Summary parsed at:2026-06-11 04:37:07 UTC
Predicate devices
3—
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Not ingested
IPL Hair Removal Device Joy Version
IPL Hair Removal
K223618 references 3 predicate/reference devices
Cited as predicate
5IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
5 submissions cite K223618 as a predicate
