IOLAB Corp.; Premarket Approval of the Models LI30U, LI32U, and LI41U SOFLEXSUPTM Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses

الملخص

The Food and Drug Administration (FDA) is announcing its approval of the application by IOLAB Corp., Claremont, CA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Models LI30U, LI32U, and LI41U SOFLEX TM ultraviolet- absorbing silicone posterior chamber intraocular lenses. After addressing the concerns of the Ophthalmic Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 2, 1994, of the approval of the application.