Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K191693 |
Device Name |
BC-5 |
Applicant |
Reveallux, Corp |
4508 38th, Suite 230 |
Columbus,
NE
68601
|
|
Applicant Contact |
Justin D Linn |
Correspondent |
FDA 510k Consultants, LLC |
1100 Del Lago Cir #104 |
Palm Beach Gardens,
FL
33410
|
|
Correspondent Contact |
John Gillespy |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/25/2019 |
Decision Date | 11/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|