PMA P010018S002

Device
VIEWPOINT CK SYSTEM
Applicant
Refractec, Inc.
PMA number
P010018
Supplement
S002
Product code
MWD
Decision date
2003-06-09
Classification
Ophthalmic
Generic name
Electrosurgical, radio frequency, refractive correction
Approval order statement
ALTERNATE TEST METHOD FOR EVALUATION OF THE RADIOFREQUENCY OUTPUT OF THE RCS-300 CONSOLE DURING FINAL DEVICE TESTING.

Current openFDA PMA Record#

Device
VIEWPOINT CK SYSTEM
Applicant
Refractec, Inc.
PMA number
P010018
Supplement
S002
Product code
MWD
Generic name
Electrosurgical, radio frequency, refractive correction
Decision date
2003-06-09
Decision code
OK30
Date received
2003-05-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE TEST METHOD FOR EVALUATION OF THE RADIOFREQUENCY OUTPUT OF THE RCS-300 CONSOLE DURING FINAL DEVICE TESTING.