| Device Classification Name |
Powered Laser Surgical Instrument
|
|---|
| 510(k) Number |
K890775 |
|---|
| Device Name |
INFRALASE - LASERGUIDE DELIVERY SYSTEM |
|---|
| Applicant |
| Ximed Medical Systems |
| 2855 Kifer Rd. |
|
Santa Clara,
CA
95050
|
|
| Applicant Contact |
DESAI |
| Correspondent |
| Ximed Medical Systems |
| 2855 Kifer Rd. |
|
Santa Clara,
CA
95050
|
|
| Correspondent Contact |
DESAI |
| Regulation Number | 878.4810 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/15/1989 |
|---|
| Decision Date | 04/21/1989 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
General & Plastic Surgery
|
|---|
| 510k Review Panel |
General & Plastic Surgery
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|