510(k) clearances

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

Shenzhen Mlay Intelligent Technology Co., , Ltd. · General, Plastic Surgery

K241106Substantially EquivalentSpecialOHT
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
General, Plastic Surgery
Address 1
302,401, Bldg. 1, # 2, Xiashiwei Rd., Huaide Community
Address 2
Fuyong St., Baoan District
Statement or summary
Summary
Product code
OHT
Zip code
518000
Applicant
Shenzhen Mlay Intelligent Technology Co., , Ltd.
Decision date
2024-05-22
Decision code
SESE
Country code
CN
Device name
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
Advisory committee
SU
Contact
Libin Liu
K number
K241106
Date received
2024-04-22
Review advisory committee
SU
Postal code
518000
Decision description
Substantially Equivalent
Clearance type
Special
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.