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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namelens, contact, orthokeratology, overnight
Generic Namelens, contact, orthokeratology, overnight
Regulation Number886.5916
Euclid Systems Corporation
2776 towerview rd.
herndon, VA 20171
PMA NumberP040029
Date Received06/21/2004
Decision Date09/29/2004
Product Code
NUU[ Registered Establishments with NUU ]
Docket Number 04M-0450
Notice Date 10/12/2004
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the jsz orthokeratology (oprifocon a) contact lenses for overnight wear. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear for the temporary reduction of myopia up to 5. 00 diopters with eyes having astigmatism up to 1. 50 diopters. The lenses may only be disinfected using a chemical disinfection system. Note: to maintain the orthokeratology 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003