Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Ophthalmic Sealant

FDA Pre-Market Approval

FDA Class 3 ·RESURE SEALANT

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus® Microstent

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Tecnis 3-Piece Multifocal IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS SK53UM & SK57UM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISPHERIC MODEL YA-60BB INTRAOCULAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA Posterior Chamber Intraocular Lenses

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY