Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K202288 |
Device Name |
Finebeam |
Applicant |
SNJ Co., Ltd. |
No. 604, Ace-Techno Tower 2, Digital-ro 31-gil 19, Guro-gu |
Seoul,
KR
08381
|
|
Applicant Contact |
Hyang-Kee Lee |
Correspondent |
Med.com |
2202 Gongwon-ro, Guro-gu |
Seoul,
KR
08295
|
|
Correspondent Contact |
Jongrak Kim |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/12/2020 |
Decision Date | 11/19/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|