510(k) clearances

Diode Laser Hair Removal System (SH-VD910)

Beijing Sea Heart International Science and Technologyco.Ltd · General, Plastic Surgery

K240520Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Beijing
Advisory committee description
General, Plastic Surgery
Address 1
Rm. 4009, Bldg. 4, Zhongke Jingwei Industrial Park
Address 2
#8 Yongchang Middle Rd.,Economic And Technological Develo
Statement or summary
Summary
Product code
GEX
Zip code
100176
Applicant
Beijing Sea Heart International Science and Technologyco.Ltd
Decision date
2024-05-20
Decision code
SESE
Country code
CN
Device name
Diode Laser Hair Removal System (SH-VD910)
Advisory committee
SU
Contact
Xiaoli He
K number
K240520
Date received
2024-02-23
Review advisory committee
SU
Postal code
100176
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
3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 3007156625, 1000523114, 3002806603, 3012294783, 3007535734, 2031934, 3033126947, 3019252665, 2521877, 1226005, 3004497289, 3006985163, 3003610527, 3030979014, 9710340, 1424785, 3026400760, 3004111573, 3006786907, 3044175602, 2032092, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436 +453 more
FEI number
3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 1000623228, 1000523114, 3002806603, 3012294783, 3007535734, 3033126947, 3019252665, 2521877, 3004497289, 3006985163, 3003610527, 3030979014, 3026400760, 3003559308, 3004111573, 3006786907, 3044175602, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436, 3001362763, 2938889, 3042953831, 3004361445 +451 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.