| Device Classification Name |
lamp, infrared, therapeutic heating
|
|---|
| 510(K) Number |
K121487 |
|---|
| Model |
LTC-900, LTC-1200
|
| Device Name |
LITECURE THERAPY COMPACT |
|---|
| Applicant |
| LITECURE, LLC |
| 250 corporate blvd. |
| suite b |
|
newark,
DE
19702
|
|
| Contact |
liang lu |
| Regulation Number | 890.5500
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/18/2012 |
|---|
| Decision Date | 06/12/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Physical Medicine
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| statement |
statement
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
