510(k) clearances

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)

Kam Yuen Plastic Products , Ltd. · General, Plastic Surgery

K260767Substantially EquivalentTraditionalOHS
Open FDA's page for this record
Third party flag
N
City
Zhongshan
Advisory committee description
General, Plastic Surgery
Address 1
# 2, Heng Feng Two Rd., Pu Jin Industrial, Konghou Town
Statement or summary
Summary
Product code
OHS
Zip code
528447
Applicant
Kam Yuen Plastic Products , Ltd.
Decision date
2026-08-31
Decision code
SESE
Country code
CN
Device name
Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)
Advisory committee
SU
Contact
Shihe Wu
K number
K260767
Date received
2026-03-09
Review advisory committee
SU
Postal code
528447
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Light Based Over The Counter Wrinkle Reduction
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3042970900, 3007744197, 3015619973, 3019887520, 3038373471, 3017619615, 3017649333, 3015415349, 3009102830, 1832894, 3021599225, 3012657194, 3019577501, 3015289316, 3012294783, 1318319, 3010027944, 3027651556, 3021282471, 3006182559, 3020900954, 9617486, 3023371360, 3013689783, 3006459199, 3042131929, 3016071154, 3017382141, 3014467408, 3016055197, 3013481783, 3008345424, 3004839404, 3007238544, 3004126239, 3030234143, 3017140525, 3038319732, 3014737458, 3016496662 +88 more
FEI number
3042970900, 3007744197, 3015619973, 3019887520, 3038373471, 3017619615, 3017649333, 3015415349, 3009102830, 1832894, 3012420078, 3012657194, 3021599225, 3019577501, 3015289316, 3012294783, 1318319, 3010027944, 3027651556, 3021282471, 3006182559, 3020900954, 3023371360, 3013689783, 3006459199, 3042131929, 3016071154, 3017382141, 3014467408, 3016055197, 3013481783, 3008345424, 3004839404, 3007238544, 3004126239, 3030234143, 3017140525, 3038319732, 3014737458, 3016496662 +88 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.