Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K993154 |
Device Name |
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM |
Applicant |
A.R.C. LASER CORP. |
2417 SOUTH 3850 WEST |
SALT LAKE CITY,
UT
84120
|
|
Applicant Contact |
DANIEL HOEFER |
Correspondent |
A.R.C. LASER CORP. |
2417 SOUTH 3850 WEST |
SALT LAKE CITY,
UT
84120
|
|
Correspondent Contact |
DANIEL HOEFER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/21/1999 |
Decision Date | 06/29/2000 |
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
|