Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ENDOTOXIN TEST METHOD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·TETRAFILCON LENSES: PREFERENCE SPHERE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TENIS 3-PC MONOFOCAL-ZA9003

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TENEO 317 Model 2

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·B AND L 70 LIDOFILCON A CONTACT LENSE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS® Foldable Acrylic IOL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT,DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Intraocular Lenses and Delivery System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·Implantable Miniature Telescope

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC10 & PC21

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHAMBER LENS MODELS 101, 101B, 101T

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·Nidek EC-5000 Excimer Laser System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Ophthalmic Viscosurgical Devices