| Device Classification Name |
light, ultraviolet, dermatological
|
|---|
| 510(k) Number |
K024020 |
|---|
| Device Name |
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM |
|---|
| Applicant |
| THERALIGHT, INC. |
| 2794 LOKER AVE. WEST,SUITE 105 |
|
CARLSBAD,
CA
92008 -6616
|
|
| Applicant Contact |
KEVIN E DALY |
| Correspondent |
| THERALIGHT, INC. |
| 2794 LOKER AVE. WEST,SUITE 105 |
|
CARLSBAD,
CA
92008 -6616
|
|
| Correspondent Contact |
KEVIN E DALY |
| Regulation Number | 878.4630
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 12/05/2002 |
|---|
| Decision Date | 01/17/2003 |
|---|
| 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
|
|---|