510(k) clearances

LED Therapy Device (QLXY-01)

Beijing Nubway S&T Co., Ltd. · General, Plastic Surgery

K261673Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Beijing
Advisory committee description
General, Plastic Surgery
Address 1
202,#5 Workshop, #1 Caida 3rd Rd. Nancai Shunyi District
Statement or summary
Summary
Product code
GEX
Zip code
101300
Applicant
Beijing Nubway S&T Co., Ltd.
Decision date
2026-09-17
Decision code
SESE
Country code
CN
Device name
LED Therapy Device (QLXY-01)
Advisory committee
SU
Contact
Xiting Fan
K number
K261673
Date received
2026-05-21
Review advisory committee
SU
Postal code
101300
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powered Laser Surgical Instrument
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3009488834, 3009380063, 3005580113, 3013619029, 3011657089, 3037047060, 3038373471, 3042255006, 3005855240, 3006849754, 3004111573, 3009649442, 3016170453, 3004378299, 1318319, 3003340844, 3043011436, 1222993, 3012322232, 3004633032, 3034456223, 3004374705, 3037966040, 3005791808, 3019906161, 3020900954, 3009383334, 3038197172, 3046005941, 2939653, 3012133441, 3015807001, 3025268687, 1319211, 3007583504, 3021349626, 1037955, 3043012240, 3009887511, 1424785 +452 more
FEI number
3009488834, 3009380063, 3005580113, 3013619029, 3011657089, 3037047060, 3038373471, 3042255006, 3005855240, 3006849754, 3004111573, 3009649442, 3016170453, 3004378299, 1318319, 3003340844, 3043011436, 3012322232, 3004633032, 3034456223, 3004374705, 3037966040, 3005791808, 3019906161, 3020900954, 3009383334, 3003067608, 3000219468, 3038197172, 3046005941, 2939653, 3002900199, 3012133441, 3015807001, 3025268687, 1319211, 3007583504, 3021349626, 1037955, 3043012240 +450 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.