This article is more than 5 years old. Information may no longer be current.
Paragon receives FDA approval for expanded indications
Click Here to Manage Email Alerts
MESA, Ariz. — The U.S. Food and Drug Administration has approved expanded indications for Paragon HDS, Paragon Thin, Paragon HDS 100, FluoroPerm 30, 60, 92 and FluoroPerm 151, according to a press release from Paragon Vision Sciences.
The FDA approval "is indicated for the management of irregular corneal conditions," the release said. The gas permeable materials are indicated for keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, post-radial keratotomy and post-LASIK. The materials are also approved for plasma treatment.
"We are extremely excited about the recent FDA approval for our gas permeable product line," said Joe Sicari, Paragon president and CEO. "Having this expanded indication approval will allow eye care practitioners a broader choice for scleral and semi-scleral lens designs based on the individual needs of the patient."
The release also noted that the materials can be made in chord diameters of 7 mm to 16 mm, with the exception of the FluoroPerm 30 and Paragon Thin, which can be manufactured to only 11.5 mm.