PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Lens, Contact, Orthokeratology, Overnight

FDA Premarket Approval P050031

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the paragon z crt (tisilfocon a) rigid gas permeable contact lenses for contact lens corneal refractive therapy. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in the contact lens corneal refractive therapy fitting program for the temporary reduction of myopia up to 6. 00 diopters in eyes with astigmatism up to 1. 75 diopters. The lenses may be disinfected using only a chemical disinfection system. Note: to maintain the contact lens corneal refractive therapy effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e. G. , night driving), visual fluctuations and changes in intended correction.

• Device: PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY
• Classification Name: Lens, Contact, Orthokeratology, Overnight
• Generic Name: Lens, Contact, Orthokeratology, Overnight
• Applicant: PARAGON VISION SCIENCES
• Date Received: 2005-08-26
• Decision Date: 2006-11-16
• Notice Date: 2006-11-27
• PMA: P050031
• Supplement: S
• Product Code: NUU
• Docket Number: 06M-0473
• Advisory Committee: Ophthalmic
• Expedited Review: No
• Combination Product: No
• Applicant Address: PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P050031		Original Filing
S009	2022-04-15	30-day Notice
S008
S007	2020-08-05	30-day Notice
S006	2020-08-04	30-day Notice
S005	2019-03-13	Normal 180 Day Track No User Fee
S004
S003	2019-02-04	Real-time Process
S002
S001	2010-10-25	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
B22222	P050031	000
B22221	P050031	000