Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K182270 |
Device Name |
Cellene CO2 Laser System |
Applicant |
Bio-Med USA Inc. |
27 New England Drive |
Ramsey,
NJ
07446
|
|
Applicant Contact |
Young Chi |
Correspondent |
Bio-Med USA Inc. |
27 New England Drive |
Ramsey,
NJ
07446
|
|
Correspondent Contact |
Young Chi |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/22/2018 |
Decision Date | 11/02/2018 |
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
|