Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K191501 |
Device Name |
PALLAS 308/311 Solid-State UV Laser System |
Applicant |
Laseroptek Co., Ltd. |
#116, #117, #203, #204 Hyundai I Valley, 31, |
Galmachi-ro, 244beon-gil, Jungwon-gu |
Gyeonggido,
KR
13212
|
|
Applicant Contact |
Hong Chu |
Correspondent |
MDR Solutions Co., Ltd. |
1435 Kanchanapisek Rd., Bang Khae Nuea |
Bangkok,
TH
10160
|
|
Correspondent Contact |
Paweena U-Thainual |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/06/2019 |
Decision Date | 01/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|