510(k) clearances

LED Light Therapy Masks (PE748, PE749, PE756)

Duplex International Trading Limited · General, Plastic Surgery

K261496Substantially EquivalentTraditionalOHS
Open FDA's page for this record
Third party flag
N
City
Hongkong
Advisory committee description
General, Plastic Surgery
Address 1
B1, 10/F, Block 2, Golden Dragon Ind Center, 162-170 Tai Lin
Statement or summary
Summary
Product code
OHS
Applicant
Duplex International Trading Limited
Decision date
2026-08-04
Decision code
SESE
Country code
CN
Device name
LED Light Therapy Masks (PE748, PE749, PE756)
Advisory committee
SU
Contact
JunYi Xing
K number
K261496
Date received
2026-05-06
Review advisory committee
SU
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.