510(k) clearances

1060nm laser body slimming machine

Hebei JT Medical Co., Ltd. · General, Plastic Surgery

K240658Substantially EquivalentTraditionalPKT
Open FDA's page for this record
Third party flag
N
City
Hebei
Advisory committee description
General, Plastic Surgery
Address 1
C12 Hegu Industrial Park, Chaoyang Rd.,
Address 2
Development Zone Zhuozhou City
Statement or summary
Summary
Product code
PKT
Applicant
Hebei JT Medical Co., Ltd.
Decision date
2024-05-13
Decision code
SESE
Country code
CN
Device name
1060nm laser body slimming machine
Advisory committee
SU
Contact
Karen Liu
K number
K240658
Date received
2024-03-08
Review advisory committee
SU
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Medical specialty description
General, Plastic Surgery
Regulation number
878.5400
Device class
2
Registration number
3012294783, 3014980461, 3001431138, 1222993, 3021315370, 3008915316, 3025379728, 3004505220, 3006515340, 3026540840, 3026038437, 3013602304, 3027619554, 3007120647, 3042351542, 3031944951, 3007712511
FEI number
3012294783, 3014980461, 3001431138, 3021315370, 3008915316, 3025379728, 3004505220, 3006515340, 3026540840, 3026038437, 3013602304, 1000120578, 3027619554, 3007120647, 3042351542, 3031944951, 3007712511
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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.