510(k) clearances

Dental Diode Laser Device (Laser-Pen)

Guilin Kevin Peter Technology Co., Ltd. · General, Plastic Surgery

K261047Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Guilin
Advisory committee description
General, Plastic Surgery
Address 1
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Statement or summary
Summary
Product code
GEX
Zip code
541100
Applicant
Guilin Kevin Peter Technology Co., Ltd.
Decision date
2026-09-18
Decision code
SESE
Country code
CN
Device name
Dental Diode Laser Device (Laser-Pen)
Advisory committee
SU
Contact
Libin Zhang
K number
K261047
Date received
2026-03-31
Review advisory committee
DE
Postal code
541100
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.