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)

Shenzhen Ulike Smart Electronics Co., Ltd.

Country / region:China (CN)Submission type:Special

Product code OHT· 21 CFR 878.4810

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Company

Shenzhen Ulike Smart Electronics Co., Ltd.

China (CN)

Product code

OHT

21 CFR 878.4810

Predicate devices

Cited in this 510(k)

Cited as predicate

Device details

FDA 510(k) registration fields

K number: K240652
Device 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)
Company: Shenzhen Ulike Smart Electronics Co., Ltd.
Country / region: China(CN)
Product code: OHT
Device class: Class 2
Regulation number: 21 CFR 878.4810
Date received: 2024-03-07
Decision date: 2024-04-04
Submission type: Special
Technology type: IPL(AI inferred)
Clinical applications: BodyFaceLegsBikini / Brazilian
Primary application: Body
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.

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.

Summary parsed at:2026-06-11 04:45:31 UTC

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