Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT R3 (PHEMFILCON A) LENSES/SHELF LIFE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ZYME(TM) ENZYAMTIC CLEANER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) WITH THE ACRYSERT DELIVERY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus Microstent

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX INTRAOCULAR LENS MODEL 570C

Ophthalmic Sealant

FDA Pre-Market Approval

FDA Class 3 ·RESURE SEALANT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·KESTREL NO. 695 HEATER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II & SHELLGEL SODIUM HYALURONATE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS EXTENDED WEAR CONTACT LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti