510(k) clearances

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)

Theralaser Medtech (China) Co., Ltd. · General, Plastic Surgery

K240874Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
Ingxiang High-Tech Industrial Park Chang
Advisory committee description
General, Plastic Surgery
Address 1
Rm. 407-408, #4 Bldg., Hunan Science And Technology
Address 2
Industrial Park, Jinzhou N. Rd.Lopment Zone
Statement or summary
Statement
Product code
GEX
Zip code
410600
Applicant
Theralaser Medtech (China) Co., Ltd.
Decision date
2024-05-28
Decision code
SESE
Country code
CN
Device name
Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
Advisory committee
SU
Contact
Danhong Huang
K number
K240874
Date received
2024-03-29
Review advisory committee
SU
Postal code
410600
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.