PMA P010018S009

Device: VIEWPOINT CK SYSTEM
Applicant: Refractec, Inc.
PMA number: P010018
Supplement: S009
Product code: MWD
Decision date: 2006-04-06
Classification: Ophthalmic
Generic name: Electrosurgical, radio frequency, refractive correction
Approval order statement: APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS FOR CK TREATMENT TO IMPROVE NEAR VISION IN THE EMMETROPIC AND HYPEROPIC PRESBYOPES.

Current openFDA PMA Record#

Device: VIEWPOINT CK SYSTEM
Applicant: Refractec, Inc.
PMA number: P010018
Supplement: S009
Product code: MWD
Generic name: Electrosurgical, radio frequency, refractive correction
Decision date: 2006-04-06
Decision code: APPR
Date received: 2006-01-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS FOR CK TREATMENT TO IMPROVE NEAR VISION IN THE EMMETROPIC AND HYPEROPIC PRESBYOPES.