Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 27
- Latest Decision
- 2018-05-17
Clearances · page 5 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| DEN170086 | TrueTear Intranasal Tear Neurostimulator | Allergan | QBR | Class II | 2018-05-17 |
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | Menicon Co, Ltd. | LPL | Class II | 2018-05-16 |
| K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2018-04-27 |
| K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | Contamac, Ltd. | HQD | Class II | 2018-04-25 |
| K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | Visco Vision, Inc. | LPL | Class II | 2018-04-20 |
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | HNO | Class I | 2018-04-13 |
| DEN180001 | IDx-DR | Idx, LLC | PIB | Class II | 2018-04-11 |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2018-04-10 |
| K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2018-04-10 |
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed OY | HKI | Class II | 2018-04-05 |
| K173958 | OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens | Visco Vision, Inc. | LPL | Class II | 2018-04-03 |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | OOE | Class II | 2018-03-27 |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | Bausch and Lomb, Incorporated | MRC | Class II | 2018-03-27 |
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG | Paragon Vision Sciences | HQD | Class II | 2018-03-16 |
| K180195 | Frigitronics adapter | Phakos | HRN | Class II | 2018-03-16 |
| K173980 | Specular Microscope CEM-530 | Nidek Co., Ltd. | NQE | Class II | 2018-03-14 |
| K173904 | CATS Tonometer Prism | Cats Tonometer, LLC | HKY | Class II | 2018-03-09 |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | OOE | Class II | 2018-03-02 |
| K173707 | P200TE | Optos Plc. | OBO | Class II | 2018-02-28 |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | Menicon Co, Ltd. | LPL | Class II | 2018-02-22 |
| K173119 | DRI OCT Triton | Topcon Corporation | OBO | Class II | 2018-01-19 |
| K171313 | EM-4000 Specular Microscope | Tomey Corporation | NQE | Class II | 2018-01-19 |
| K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | ORZ | Class II | 2017-12-26 |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | HJO | Class II | 2017-12-21 |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | MSS | Class I | 2017-12-15 |
| K172692 | Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens | Tangible Science, LLC | LPL | Class II | 2017-12-13 |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | MSS | Class I | 2017-12-11 |
| K171447 | OxyPure Color Silicone Hydrogel Soft Contact Lenses | Visco Vision, Inc. | LPL | Class II | 2017-12-05 |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | LRX | Class II | 2017-12-04 |
| K172925 | Contact Lens Case, Model: A-1, B-1 | P L Overseas Limited | LRX | Class II | 2017-11-30 |
| K171488 | PSLT for PASCAL Streamline | Topcon Medical Laser Systems, Inc. | HQF | Class II | 2017-11-27 |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | Bausch & Lomb, Incorporated | MRC | Class II | 2017-11-27 |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | Bausch & Lomb, Incorporated | LRX | Class II | 2017-11-17 |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | MRC | Class II | 2017-11-16 |
| K173086 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | LPL | Class II | 2017-11-07 |
| K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor | Heidelberg Engineering GmbH | OBO | Class II | 2017-11-01 |
| K172994 | EPI K Console | Moria SA | HNO | Class I | 2017-10-26 |
| K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2017-10-25 |
| K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | Contamac, Ltd. | HQD | Class II | 2017-10-24 |
| K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | OOE | Class II | 2017-10-19 |
| K171125 | Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | Tangible Science, LLC | LPL | Class II | 2017-10-18 |
| K172728 | Applanation tonometer AT-1 | Takagi Seiko Co., Ltd. | HKY | Class II | 2017-10-17 |
| K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | HJO | Class II | 2017-10-06 |
| K170183 | Cetus system, Cetus probe | A.R.C Laser GmbH | HQE | Class II | 2017-09-27 |
| K172314 | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) | Art Optical Contact Lens, Inc. | HQD | Class II | 2017-09-20 |
| K170286 | Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA | Largan Medical Co., Ltd. | LPL | Class II | 2017-09-18 |
| K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | HKI | Class II | 2017-09-15 |
| K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | MSS | Class I | 2017-09-06 |
| K172002 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | OOE | Class II | 2017-08-25 |
| K171950 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) | Visionary Optics, LLC | HQD | Class II | 2017-08-16 |
| K171337 | LENSAR Laser System fs 3D (LLS-fs 3D) | Lensar, Inc. | OOE | Class II | 2017-08-10 |
| K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2017-08-09 |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | KYF | Class II | 2017-08-08 |
| K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses | Contamac, Ltd. | HQD | Class II | 2017-08-01 |
| K170067 | Easyret | Quantel Medical | HQF | Class II | 2017-07-25 |
| K162778 | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | HJO | Class II | 2017-07-21 |
| K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | HQD | Class II | 2017-07-17 |
| K171539 | Contact Lens Case | E-Link Plastic & Metal Industrial Co.,Ltd | LRX | Class II | 2017-07-14 |
| K171163 | Contact Lens Case Round Glasses | Fiftytwoways, Ltd. | LRX | Class II | 2017-06-27 |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Nidek Co., Ltd. | HQF | Class II | 2017-06-23 |
| K163195 | PRIMUS | Carl Zeiss Suzhou Co., Ltd. | OBO | Class II | 2017-06-21 |
| K163632 | Katalyst Cyclophotocoagulation Probe | Katalyst Surgical, LLC | LQJ | Class II | 2017-06-15 |
| K163475 | iVue | Optovue, Inc. | OBO | Class II | 2017-06-09 |
| K170591 | Altomed Malhotra Platinum Segments | Altomed Limited | MML | Class II | 2017-06-06 |
| K170655 | Zepto | Mynosys Cellular Devices, Inc. | PUL | Class II | 2017-06-02 |
| K170001 | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2017-06-02 |
| K171157 | PolyDev Soft Contact Lenses | Polydev , Ltd. | LPL | Class II | 2017-06-02 |
| K162684 | SL 220 | Carl Zeiss Meditec, AG | HJO | Class II | 2017-05-31 |
| K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2017-05-31 |
| K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | OOE | Class II | 2017-05-19 |
| K163564 | SLIT LAMP SL-2000 | Nidek Co., Ltd. | HJO | Class II | 2017-05-19 |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | OOE | Class II | 2017-05-05 |
| K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | HRN | Class II | 2017-05-03 |
| DEN160030 | Oculeve Intranasal Tear Neurostimulator Device | Oculeve, Inc. | PQJ | Class II | 2017-04-24 |
| K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | HKX | Class II | 2017-04-24 |
| K170052 | Stellaris Elite vision enhancement system | Bausch+Lomb | HQC | Class II | 2017-04-19 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | HJO | Class II | 2017-04-14 |
| K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | HQC | Class II | 2017-04-14 |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | LPN | Class II | 2017-04-11 |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | Optomed OY | HKI | Class II | 2017-04-11 |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | HJO | Class II | 2017-04-06 |
| K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | HQC | Class II | 2017-03-24 |
| K170335 | Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens | Valley Contax, Inc. | HQD | Class II | 2017-03-24 |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Alcon Research, Ltd. | MLZ | Class II | 2017-03-22 |
| K163343 | Icare HOME tonometer | Icare Finland OY | HKY | Class II | 2017-03-21 |
| K170164 | 3D OCT-1 Maestro | Topcon Corporation | OBO | Class II | 2017-03-03 |
| K161607 | VISULUX | Carl Zeiss Meditec, AG | HJO | Class II | 2017-02-23 |
| K161764 | SLIT LAMP, Model: YF-100 | Chongqing Yeasn Science-Technology Co., Ltd. | HJO | Class II | 2017-02-16 |
| K163551 | LenSx Laser System | Alcon Laboratories, Inc. | OOE | Class II | 2017-02-03 |
| K160591 | D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV | HRN | Class II | 2017-01-23 |
| K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2017-01-18 |
| K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd | LPL | Class II | 2017-01-04 |
| K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2016-12-19 |
| K162783 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | OBO | Class II | 2016-12-09 |
| K162869 | Contact Lens Case | Ningbo Yinzhou Zonghai Artware Co., Ltd. | LRX | Class II | 2016-12-09 |
| K161972 | Slit Lamp SL-D301 | Topcon Corporation | HJO | Class II | 2016-12-09 |
| K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2016-12-08 |
| K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | LPL | Class II | 2016-11-30 |
| K161776 | Lenstec LC Injection system | Lenstec, Inc. | MSS | Class I | 2016-11-29 |
| K161819 | NNR06 Multi-Purpose Solution | Bausch & Lomb, Incorporated | LPN | Class II | 2016-11-25 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.