510(k) clearances

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

Wuhan Pioon Technology Co., Ltd. · General, Plastic Surgery

K262426Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Wuhan
Advisory committee description
General, Plastic Surgery
Address 1
12th Floor, Bldg. 1, Innovative Unit, R&D Center Project, Ma
Address 2
# 16 Fozuling 3rd Rd., E. Lake High-Tech Development Zone,
Statement or summary
Summary
Product code
GEX
Zip code
430205
Applicant
Wuhan Pioon Technology Co., Ltd.
Decision date
2026-09-10
Decision code
SESE
Country code
CN
Device name
Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
Advisory committee
SU
Contact
Feng Zhang
K number
K262426
Date received
2026-07-16
Review advisory committee
SU
Postal code
430205
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.