Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.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
Product code
OHT
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
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)
- 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
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K233679 as a predicate