Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K230340 |
Device Name |
Lucas Plus |
Applicant |
AMT Engineering Co., Ltd |
811-812 Byoksan Technopia 560, Duchon Daero |
Jungwon gu, SeongNam-si |
Gyeonggi do,
KR
13230
|
|
Applicant Contact |
SeoungSoo Choi |
Correspondent |
Bio-Med USA Inc |
27 New England Dr |
Ramsey,
NJ
07446
|
|
Correspondent Contact |
Young Chi |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/07/2023 |
Decision Date | 05/04/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|