510(k) clearances

Pastelle Pro

Wontech Co., Ltd. · General, Plastic Surgery

K241527Substantially EquivalentTraditionalGEX
Open FDA's page for this record
Third party flag
N
City
64, Techno 8-Ro, Yuseong-Gu
Advisory committee description
General, Plastic Surgery
Address 1
64, Techno 8-Ro, Yuseong-Gu
Statement or summary
Summary
Product code
GEX
Zip code
34028
Applicant
Wontech Co., Ltd.
Decision date
2025-02-14
Decision code
SESE
Country code
KR
Device name
Pastelle Pro
Advisory committee
SU
Contact
Hyun Sik Yoon
K number
K241527
Date received
2024-05-30
Review advisory committee
SU
Postal code
34028
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.