510(k) clearances

LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)

Shenzhen Qianyu Technology Co., Ltd. · General, Plastic Surgery

K261851Substantially EquivalentTraditionalOHS
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
General, Plastic Surgery
Address 1
Rm. 601, Han'S Technology Center. #9988, Shennanavenue, Mali
Statement or summary
Summary
Product code
OHS
Zip code
518000
Applicant
Shenzhen Qianyu Technology Co., Ltd.
Decision date
2026-08-04
Decision code
SESE
Country code
CN
Advisory committee
SU
Contact
Li Guoyang
K number
K261851
Date received
2026-06-03
Review advisory committee
SU
Postal code
518000
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)

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.