Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K003705 |
Device Name |
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 |
Applicant |
PHOTO MEDEX, INC. |
2431 IMPALA DR. |
CARLSBAD,
CA
92008 -7227
|
|
Applicant Contact |
AL MEMMOLO |
Correspondent |
PHOTO MEDEX, INC. |
2431 IMPALA DR. |
CARLSBAD,
CA
92008 -7227
|
|
Correspondent Contact |
AL MEMMOLO |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/01/2000 |
Decision Date | 03/01/2001 |
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
|