Manufacturer
El Global Trade, Ltd.IPL400
Country / Region:United States (US)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
- K250384
- Device name
- IPL400
- Company
- El Global Trade, Ltd.
- Country / Region
- United States(US)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-02-11
- Decision date
- 2025-05-23
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- ArmsLegsOther
- Primary application
- Other
- Classification source
- AI classified
Indications for Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window 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. Applicable skin types: Fitzpatrick Skin Types I-V. Treatment area: Large areas (e.g. arms, legs, chest) and small areas (e.g. lip).
Intended Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window 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
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window 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 ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
Summary parsed at:2026-06-11 04:28:29 UTC
Predicate devices
4—
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Not ingested
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
K250384 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250384 as a predicate
