Device Classification Name |
laser, comb, hair
|
510(k) Number |
K181253 |
Device Name |
Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup |
Applicant |
PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC |
1499 NW 79th Avenue |
Miami,
FL
33126
|
|
Applicant Contact |
Ira Nusbaum |
Correspondent |
Grace Consulting, LLC |
6615 Lake Shore Drive, Ste 806 |
Minneapolis,
MN
55423
|
|
Correspondent Contact |
Ronald Berglund |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 05/11/2018 |
Decision Date | 08/10/2018 |
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
|
|
|