Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K173729 |
Device Name |
REVIAN RED |
Applicant |
PhotonMD, Inc |
627 Davis Drive, Suite 400 |
Morrisville,
NC
27560
|
|
Applicant Contact |
William A Knape |
Correspondent |
PhotonMD, Inc |
627 Davis Drive, Suite 400 |
Morrisville,
NC
27560
|
|
Correspondent Contact |
William A Knape |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 12/06/2017 |
Decision Date | 02/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|