| Device Classification Name |
Powered Laser Surgical Instrument
|
|---|
| 510(k) Number |
K120737 |
|---|
| Device Name |
TRIA LASER HAIR REMOVAL SYSTEM |
|---|
| Applicant |
| Tria Beauty, Inc. |
| 555 13th St., NW |
| Columbia Sq. |
|
Washington D.C.,
DC
20004
|
|
| Applicant Contact |
JONATHAN KAHAN |
| Correspondent |
| Tria Beauty, Inc. |
| 555 13th St., NW |
| Columbia Sq. |
|
Washington D.C.,
DC
20004
|
|
| Correspondent Contact |
JONATHAN KAHAN |
| Regulation Number | 878.4810 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/09/2012 |
|---|
| Decision Date | 09/13/2012 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|