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Ophthalmic

6,560 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033)CooperVision, Inc.2025-12-23
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S043)Rayner Intraocular Lenses , Ltd.2025-12-23
ADATO SIL-OL 5000 Silicone Oils (P910071/S019)Bausch & Lomb2025-12-22
VisuMax; VISUMAX 800 (P150040/S020)Carl Zeiss Meditec, Inc.2025-12-18
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032)CooperVision, Inc.2025-12-17
ACUVUE CONTACT LENS (N18033/S112)Vistakon, Johnson & Johnson Vision Products, Inc.2025-12-16
Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht (P810031/S081)Johnson & Johnson Surgical Vision, Inc.2025-12-16
Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) (P860022/S061)Bausch & Lomb2025-12-16
Boston Orthokeratology (oprifocon A) (P010062/S015)Bausch & Lomb2025-12-16
TECNIS SIMPLICITY™ Delivery System (P980040/S179)Johnson & Johnson Surgical Vision, Inc.2025-12-16
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S141)Vistakon, Division of Johnson & Johnson Vision Car2025-12-16
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S045)Alcon Laboratories, LLC2025-12-12
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S159)Alcon Laboratories, Inc.2025-12-12
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117)Alcon Research, Ltd.2025-12-12
Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193)CooperVision, Inc.2025-12-11
Biornedics 55 Asphere and Biornedies Torie (Ocuftlcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S056)The Cooper Companies2025-12-11
Visian® Toric Implantable Collamer® Lens (TICL) (P030016/S049)STAAR Surgical Company2025-12-10
Sofmed® breathables™ XW NEXT (P080011/S191)CooperVision, Inc.2025-12-05
Softec HD; Softec I; Softec HDO; Softec HDM (P090022/S047)Lenstec, Inc.2025-12-04
ClearView 3 (P200020/S010)Lenstec, Inc.2025-12-04
Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses (P170035/S019)Bausch and Lomb, Inc.,2025-12-04
VISIAN ICL (IMPLANTABLE COLLAMER LENS) (P030016/S048)STAAR Surgical Company2025-11-14
Healon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet ™ PRO II Dual Pack Sodium Hya (P810031/S080)Johnson & Johnson Surgical Vision, Inc.2025-10-28
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031)CooperVision, Inc.2025-10-28
TECNIS Symfony Toric II OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System, Models DXW150-375; (P980040/S178)Johnson & Johnson Surgical Vision, Inc.2025-10-24
Bausch & Lomb SofLens® (polymacon) Contact Lenses (N16895/S107)Bausch & Lomb, Inc.2025-10-24
VISUMAX 800 Femtosecond Laser (P150040/S023)Carl Zeiss Meditec, Inc.2025-10-16
Ophthalin; Nuvisc; Anikavisc (P000046/S031)Anika Therapeutics, Inc.2025-10-15
RayOne EMV Toric (P060011/S039)Rayner Intraocular Lenses , Ltd.2025-10-09
Light Adjustable Lens and Light Delivery Device (P160055/S052)Rxsight, Inc.2025-10-08
Capsular Tension Ring (275,276); RingJect (375,376) (P030023/S012)Ophtec BV2025-10-06
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S069)Alcon Research, Ltd.2025-10-03
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D (P840064/S091)Alcon Laboratories2025-10-03
Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric, RayOne Aspheric RAO600C, RayOne Spheric RAO100C and RayOne EMV (P060011/S042)Rayner Intraocular Lenses , Ltd.2025-10-01
Akreos Posterior Chamber Intraocular Lens (P060022/S037)Bausch & Lomb, Inc.2025-09-30
Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192)CooperVision, Inc.2025-09-22
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116)Alcon Research, Ltd.2025-09-18
Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le (P190018/S044)Alcon Laboratories, LLC2025-09-18
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S158)Alcon Laboratories, Inc.2025-09-18
ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses (P170035/S018)Bausch and Lomb, Inc.,2025-09-15
TECNIS Odyssey IOL with TECNIS SIMPLICITY Delivery System (DRN00V); TECNIS Odyssey Toric II IOLs with TECNIS SIMPLICITY (P980040/S174)Johnson & Johnson Surgical Vision, Inc.2025-09-11
TECNIS Foldable Acrylic IOL with OptiEdge (P990080/S062)Johnson & Johnson Surgical Vision, Inc.2025-09-10
FINEVISION HP Trifocal IOLs (P240038)Beaver Visitec International, Inc.2025-09-10
TECNIS Multifocal 3-Piece IOL (P080010/S027)Johnson & Johnson Surgical Vision, Inc.2025-09-10
SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (P980040/S171)Johnson & Johnson Surgical Vision, Inc.2025-09-10
TECNIS 3-Piece Multifocal, Model ZMA00 (P080010/S029)Johnson & Johnson Surgical Vision, Inc.2025-09-02
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055/S045)Rxsight, Inc.2025-09-02
TECNIS™ Toric II 1-Piece IOLs, ZCU TECNIS Symfony Toric II Extended Range of Vision IOLs, ZXU TECNIS Eyhance Toric II IO (P980040/S177)Johnson & Johnson Surgical Vision, Inc.2025-09-02
TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 (P990080/S064)Johnson & Johnson Surgical Vision, Inc.2025-09-02
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S157)Alcon Laboratories, Inc.2025-08-25
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115)Alcon Research, Ltd.2025-08-25
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, (P190018/S043)Alcon Laboratories, LLC2025-08-25
Visumax; VISUMAX 800 (P150040/S021)Carl Zeiss Meditec, Inc.2025-08-21
up&up Monthly Performance + (P080011/S184)CooperVision, Inc.2025-08-20
iWear oxygen presbyopia (P080011/S186)CooperVision, Inc.2025-08-20
CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P (P100016/S022)Carl Zeiss Meditec Production, LLC2025-08-20
ClearView 3 Lens (P200020/S009)Lenstec, Inc.2025-08-12
Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM (P090022/S046)Lenstec, Inc.2025-08-12
IC-8 Apthera Intraocular Lens (IOL) (P210005/S011)Acu Focus, Inc.2025-08-04
Biomedics 55 Asphere; Biomedics Toric (P890023/S055)The Cooper Companies2025-07-31
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S030)CooperVision, Inc.2025-07-30
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005/S003)Bausch & Lomb, Inc.2025-07-30
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S068)Alcon Research, Ltd.2025-07-25
VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device (P840064/S090)Alcon Laboratories2025-07-25
up&up Monthly Performance, up&up Monthly Performance XR, up&up Monthly Performance for Astigmatism, up&up Monthly Perfor (P080011/S180)CooperVision, Inc.2025-07-23
TECNIS Odyssey Toric II IOL with TECNIS SIMPLICITY Delivery System, Model DRT (P980040/S175)Johnson & Johnson Surgical Vision, Inc.2025-07-22
TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 (P990080/S063)Johnson & Johnson Surgical Vision, Inc.2025-07-22
Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S036)Bausch & Lomb, Inc.2025-07-22
TECNIS 3-Piece Multifocal, Model ZMA00 (P080010/S028)Johnson & Johnson Surgical Vision, Inc.2025-07-22
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, (P190018/S042)Alcon Laboratories, LLC2025-07-18
Biofinity XR Toric (comfilcon A) (P080011/S190)CooperVision, Inc.2025-07-14
RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) (P160055/S051)Rxsight, Inc.2025-07-14
Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035)Bausch & Lomb, Inc.2025-07-09
comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S189)CooperVision, Inc.2025-06-23
Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses (P190018/S039)Alcon Laboratories, LLC2025-06-18
AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (P930014/S152)Alcon Laboratories, Inc.2025-06-18
enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060)Bausch & Lomb, Inc.2025-06-18
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111)Alcon Research, Ltd.2025-06-18
MiSight 1 Day (omafilcon A) (P180035/S029)CooperVision, Inc.2025-06-17
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S028)CooperVision, Inc.2025-06-17
C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph (P060011/S041)Rayner Intraocular Lenses , Ltd.2025-06-12
Light Adjustable Lens, Light Delivery System (P160055/S046)Rxsight, Inc.2025-06-11
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S172)Johnson & Johnson Surgical Vision, Inc.2025-06-09
enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059)Bausch & Lomb, Inc.2025-05-30
Hydrus® Microstent (P170034/S015)Alcon Research, LLC2025-05-30
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004)Bausch & Lomb, Inc.2025-05-30
Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System (P980040/S173)Johnson & Johnson Surgical Vision, Inc.2025-05-29
VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S140)Vistakon, Division of Johnson & Johnson Vision Car2025-05-28
MEL 90 EXCIMER LASER SYSTEM (P060004/S009)Carl Zeiss Meditec, Inc.2025-05-23
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact (P040029/S023)Euclid Vision Corporation2025-05-23
Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses Extended Wear (P080011/S188)CooperVision, Inc.2025-05-20
Light Adjustable Lens and Light Delivery Device (P160055/S044)Rxsight, Inc.2025-05-19
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S027)CooperVision, Inc.2025-05-14
Light Adjustable Lens and Light Delivery Device (P160055/S048)Rxsight, Inc.2025-05-12
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S026)CooperVision, Inc.2025-05-05
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055/S047)Rxsight, Inc.2025-05-02
INTACS® Corneal Implants (P980031/S014)Addition Technology2025-05-02
Biofinity Family (comfilcon A) soft (hydrophilic) contact lenses for extended wear (P080011/S187)CooperVision, Inc.2025-05-02
HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S078)Johnson & Johnson Surgical Vision, Inc.2025-05-01
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S006)Alcon Research, LLC2025-04-30
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