Device Classification Name |
laser, comb, hair
|
510(k) Number |
K180460 |
Device Name |
Theradome LH40 |
Applicant |
Theradome, Inc. |
4900 Hopyard Road, Suite 100 |
Pleasanton,
CA
94588
|
|
Applicant Contact |
Tamim Hamid |
Correspondent |
Jacqueline A. Hauge |
23300 Manning Trail N |
Scandia,
MN
55073
|
|
Correspondent Contact |
Jacqueline A. Hauge |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 02/20/2018 |
Decision Date | 05/18/2018 |
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
|
|
|