Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT/DISCOVISC/DUOVISC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 13060 UV ABSORBING POSTERIOR CHAMBER LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·X-70 SOFT CONTACT LENS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 120 POSTERIOR CHAMBER INTRAOCULAR LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV, HEALON5 PRODUCTS, HEALON ULTIMATE DUAL PACK, AND H

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ENVISTA HYDROPHOBIC INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC INTRAOCULAR LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Frequency Xcel Toric (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses. / Frequency Xcel Toric XR (methaf

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Silikon 1000

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTRAOCULAR LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES

Ophthalmic Sealant

FDA Pre-Market Approval

FDA Class 3 ·ReSure Sealant