| Device Classification Name |
Laser, Comb, Hair
|
|---|
| 510(k) Number |
K110233 |
|---|
| Device Name |
HAIRMAX LASERCOMB |
|---|
| Applicant |
| Lexington International, LLC |
| 1400 Sixteenth St., NW |
| Suite 400 |
|
Washington,
DC
20036
|
|
| Applicant Contact |
CASPER E ULDRIKS ESQ. |
| Correspondent |
| Lexington International, LLC |
| 1400 Sixteenth St., NW |
| Suite 400 |
|
Washington,
DC
20036
|
|
| Correspondent Contact |
CASPER E ULDRIKS ESQ. |
| Regulation Number | 890.5500 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/26/2011 |
|---|
| Decision Date | 05/27/2011 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Physical Medicine
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Type |
Traditional
|
|---|
| Clinical Trials |
NCT00981461
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|