Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K062963 |
Device Name |
PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 |
Applicant |
RA MEDICAL SYSTEMS, INC. |
2270 CAMINO VIDA ROBLE |
SUITE L |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
DEAN IRWIN |
Correspondent |
RA MEDICAL SYSTEMS, INC. |
2270 CAMINO VIDA ROBLE |
SUITE L |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
DEAN IRWIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/29/2006 |
Decision Date | 04/03/2007 |
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
|
Recalls |
CDRH Recalls
|