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)

Shenzhen Ulike Smart Electronics Co., Ltd.

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

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: K240649
Device 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)
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: 2024-06-21
Submission type: Traditional
Technology type: IPL(AI inferred)
Clinical applications: FaceBodyLegsBikini / 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 04:45:21 UTC

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