Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX EXCIMER LASER SYSTEM

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SCANLENS (SCAFILCON A CONTACT LENS)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER MODEL C

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER IOL'S

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ONE PIECE SOFT ACRYLIC INTRAOCULAR LENS (IOL)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC & AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LENSTEC SOFTEC HD PCIOL

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT(TM)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MERIDIAN INTRAOCULAR LENSES

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy