Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K113097 |
Device Name |
LASER HELMET |
Applicant |
THERADOME INC. |
1001 BEAR ISLAND RD, |
SUITE 136 |
SUMMERVILLE,
SC
29483
|
|
Applicant Contact |
LARRY PETERSEN |
Correspondent |
THERADOME INC. |
1001 BEAR ISLAND RD, |
SUITE 136 |
SUMMERVILLE,
SC
29483
|
|
Correspondent Contact |
LARRY PETERSEN |
Regulation Number | 890.5500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/19/2011 |
Decision Date | 03/02/2012 |
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
|
|
|