Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
510(k) Number |
K212907 |
Device Name |
Aimanfun Lumea Comfort, A-2789/A-3588 |
Applicant |
Kam Yuen Plastic Products Ltd. |
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town |
ZhongShan,
CN
518100
|
|
Applicant Contact |
Anna Dan |
Correspondent |
Guangdong Jianda Medical Technology Co Ltd |
906 Room, Longxiang Garden, Tianhe District |
Guangzhou,
CN
|
|
Correspondent Contact |
Jett Lee |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/13/2021 |
Decision Date | 12/02/2021 |
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
|
|
|