510(k) clearances

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)

Shenzhen Ulike Smart Electronics Co., Ltd. · General, Plastic Surgery

K250194Substantially EquivalentTraditionalOHT
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
General, Plastic Surgery
Address 1
810, Bldg. 1, Xunmei Science And Technology Plz., # 8
Address 2
Keyuan Rd., Science Park Community, Yuehai Sub-District
Statement or summary
Summary
Product code
OHT
Zip code
518000
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
Decision date
2025-03-26
Decision code
SESE
Country code
CN
Device name
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
Advisory committee
SU
Contact
Yang Blue
K number
K250194
Date received
2025-01-23
Review advisory committee
SU
Postal code
518000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Light Based Over-The-Counter Hair Removal
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3010027944, 3043749884, 3007238544, 3021338880, 3012294783, 3038373471, 3031182672, 3015452693, 3013494333, 3022594978, 3017400436, 3036720861, 3018366453, 3029944286, 3039435282, 3043177840, 3043657394, 3026132991, 3029792043, 3014787341, 3023281259, 3015989868, 3014527840, 3011964664, 3010912900, 3010677917, 3015542362, 3017954802, 3014327421, 3023876598, 3011547157, 3006580954, 3021599225, 3026360847, 3033793026, 3031233197, 3038319732, 3033879491, 3010360273, 3027605738 +54 more
FEI number
3010027944, 3043749884, 3007238544, 3021338880, 3012294783, 3038373471, 3031182672, 3015452693, 3013494333, 3022594978, 3017400436, 3036720861, 3018366453, 3029944286, 3039435282, 3043177840, 3043657394, 3026132991, 3029792043, 3014787341, 3023281259, 3015989868, 3014527840, 3011964664, 3010912900, 3010677917, 3015542362, 3017954802, 3014327421, 3023876598, 3011547157, 3006580954, 3021599225, 3026360847, 3033793026, 3031233197, 3038319732, 3033879491, 3010360273, 3027605738 +53 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.