Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING ELASTIMIDE(TM) MODELS AQ-1016VL, AQ-2003VL, AQ-2010VL POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT ABSORING POSTERIOR CHAMBER INTRACOCULAR LENSES (IOLS) CEEON MODELS 911A AND 913A AND TECNIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON MODELS 911A & 913A, TECNIS Z9000

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIORCHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A & 913A, TECNIS Z9000 & Z9001

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A, 913A & TECNIS Z9000,Z9001

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A,913A 7 TECNIS Z9000,Z9001

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A,913A & TECNIS Z9000 & Z9001

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ARRAY MULTIFOCAL FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER IOL, CEEON 911A & 913A, TECNIS Z9000 & Z9001

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IOL Sterile UV-Absorbing Acrylic, Foldable Multipiece Posterior Chamber, Lenses, AcrySof™ Natural UV and Blue L

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Odyssey Toric II Intraocular Lens (IOL) With TECNIS Simplicity Delivery System, Models DRT150, DRT225, DRT300, DR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (IOL) (MODELS AR40E/AR40E/AR40M/AR40MN) & TECNIS 1 PIECE INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony™ OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS OptiBlue 1-Piece IOL, TECNIS OptiBlue Monofocal 1-Piece with Smart LOAD Delivery Technology, TECNIS 1-Piece OptiB

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony OptiBlue Extended Range of Vision (ERV) IOL, TECNIS Symfony Toric II OptiBlue Extended Range of Vision (E

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST