IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)

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: K233679
Device name: IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)
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: 2023-11-16
Decision date: 2024-01-05
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.

Summary parsed at:2026-06-11 04:43:35 UTC

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