Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K193072 |
Device Name |
Lucent : IPL |
Applicant |
LUVO Medical Technologies, Inc. |
125 Fleming Dr |
Cambridge,
CA
N1T 2B8
|
|
Applicant Contact |
Gregory Berzak |
Correspondent |
LUVO Medical Technologies, Inc. |
125 Fleming Dr |
Cambridge,
CA
N1T 2B8
|
|
Correspondent Contact |
Gregory Berzak |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/04/2019 |
Decision Date | 03/05/2020 |
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
|