510(k) clearances

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd. · General, Plastic Surgery

K261817Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Zhengzhou
Advisory committee description
General, Plastic Surgery
Address 1
3rd Floor, Bldg. 1, #101 Jinbai Rd.
Address 2
High-Tech Development Zone
Statement or summary
Summary
Product code
GEX
Zip code
450001
Applicant
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Decision date
2026-09-17
Decision code
SESE
Country code
CN
Device name
Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
Advisory committee
SU
Contact
Xinye Li
K number
K261817
Date received
2026-06-01
Review advisory committee
SU
Postal code
450001
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.