Stellar Contact Lens, Inc.; Premarket Approval of OP-3SUPTM (Lotifocon A) Rigid Gas Permeable Contact Lens (Clear and Tinted)

الملخص

The Food and Drug Administration (FDA) is announcing its approval of the application by Stellar Contract Lens, Inc., Chicago, IL, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the OP-3 TM (lotifocon A) Rigid Gas Permeable Contact Lens (Clear and Tinted). FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of January 24, 1994, of the approval of the application.