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Found 5 results
510(k) Data Aggregation
K Number
K251984Device Name
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
Manufacturer
Shenzhen Ulike Smart Electronics Co.,Ltd.
Date Cleared
2025-07-24
(27 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Ulike Smart Electronics Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250194Device Name
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
Manufacturer
Shenzhen Ulike Smart Electronics Co.,Ltd.
Date Cleared
2025-03-26
(62 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Ulike Smart Electronics Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 oversonal device for har reduction by using Intense Pulsed Light (PL). It is designed with a lamp that can emit continuously double of this surface and does not involve any cuting or pulling, reducing har growth with nearly painless pain. The device is only powered by the external pover adapter activation is by finger switch. This product adopts spphire treatment window that is suitable for multiple hair removal areas. It contains a skin contact, if the device is not in full contact with the skin, the device canot emit the treatment light pulses. Besides, the device tunction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
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K Number
K242039Device Name
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
Manufacturer
Shenzhen Ulike Smart Electronics Co.,Ltd.
Date Cleared
2024-11-06
(117 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Ulike Smart Electronics Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 (PL). It is designed with clual lamps that work together and can emit single, continuously double or triple pulses per shot. It works below the sky cutting or pulling, reducing hair growth with nearly pain. It has three modes: Fast Mode, Normal Mode and High Mode. The device is only powered by the external pover adapter and its by finger switch. This product adopts sapplive treatment window that is suitable for multiple hair removal areas. It has 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 plas the ice cooling finction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
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K Number
K240649Device Name
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
Manufacturer
Shenzhen Ulike Smart Electronics Co.,Ltd.
Date Cleared
2024-06-21
(106 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Ulike Smart Electronics Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Not Found
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K Number
K240652Device Name
Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
Manufacturer
Shenzhen Ulike Smart Electronics Co.,Ltd.
Date Cleared
2024-04-04
(28 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Ulike Smart Electronics Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Not Found
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