meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
30
Latest Decision
1998-03-04

Clearances · page 19 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974625 OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER Alcon Laboratories LPN Class II 1998-03-04
K974599 ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS) Opti-Centre Laboratories LPL Class II 1998-03-02
K974313 HYDROFERA SURGICAL SPEAR Hydrofera, LLC HOZ Class II 1998-03-02
K974724 SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT Lens Comfort, Inc. LYL Class II 1998-03-02
K980418 BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER Benz Research and Development Corp. LPL Class II 1998-02-27
K974469 MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL Mentor Corp. HQC Class II 1998-02-24
K974485 SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION Szabocsik and Assoc. LPN Class II 1998-02-24
K980085 PHACO COMMANDER Scieran Technologies, Inc. HQC Class II 1998-02-24
K974466 BOSTON ADVANCE CLEANER Polymer Technology Corp. MRC Class II 1998-02-19
K974561 MOISTAIR FLUID AIR TUBING SET American Medical Devices, Inc. KYG Class I 1998-02-19
K974467 AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 Aesculap-Meditec North America HJO Class II 1998-02-19
K974635 PARAGON LENS CARE Paragon Vision Sciences LRX Class II 1998-02-04
K974203 PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM Integrated Orbital Implants, Inc. MQU Class II 1998-02-04
K974852 NON-PRESCRIPTION SUNGLASSES Chia Hui Spectacles Mfg. Corp. HQY Class I 1998-01-30
K974860 NON-PRESCRIPTION SUNGLASSES Wenzhou Ming Ming Optical Co. , Ltd. HQY Class I 1998-01-30
K974861 NON-PRESCRIPTION SUNGLASSES Wenzhou Hindar Optical Co., Ltd. HQY Class I 1998-01-27
K971078 HYDROBRUSH (TM) KERATOME Medjet, Inc. HQS Class I 1998-01-23
K972034 MEDPOR OCULAR CONFORMER Porex Surgical, Inc. HQN Class II 1998-01-20
K974719 PHACOPAK Paradigm Medical Industries, Inc. HQC Class II 1998-01-20
K974243 KERATOME SYSTEM Insight Technologies Instruments, LLC HMY Class I 1998-01-20
K974281 ALCON CONTACT LENS CASE Alcon Laboratories LRX Class II 1998-01-20
K974511 SUNGLASSES Sun World Intl., Inc. HQY Class I 1998-01-12
K973921 BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION Bausch & Lomb, Inc. LPN Class II 1998-01-12
K974441 SUNGLASSES Hip Shing Fat Co., Ltd. HQY Class I 1998-01-09
K974004 AUTOMATED DISPOSABLE KERATOME (ADK) Lasersight Technologies, Inc. HNO Class I 1998-01-08
K963013 PREFERENCE 60 AND PREFERENCE 60 TORIC CooperVision, Inc. LPL Class II 1997-12-19
K970727 MPORT FOLDABLE LENS PLACEMENT SYSTEM Chiron Vision Corp. MSS Class I 1997-12-17
K972633 ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. HOZ Class II 1997-12-17
K971242 BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) Ipax, Inc. MML Class II 1997-12-17
K973552 OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP Bio-Vascular, Inc. MTZ Class II 1997-12-16
K973950 RETINAL CUBE Applied Spectral Imaging , Ltd. HKI Class II 1997-12-12
K973528 SUNGLASSES Jeou Jeou Long Industrial Co., Ltd. HQY Class I 1997-12-08
K973847 AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS Martin Dalsing LPL Class II 1997-12-08
K973749 FRAG COMMANDER Scieran Technologies, Inc. HQC Class II 1997-12-08
K973967 AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) Alden Optical Labs., Inc. LPL Class II 1997-12-08
K974414 MULTI Morning Calm Corp. HQY Class I 1997-12-08
K973332 ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 Alcon Laboratories LPN Class II 1997-12-02
K974179 NON-PRESCRIPTION SUNGLASSES Taipan Optical Company , Ltd. HQY Class I 1997-12-01
K972063 WHITTINGHAM ULTRACLEAN PHACO HANDPIECE William F. Whittingham HQC Class II 1997-11-25
K973217 BOSTON LIQUID ENZYMATIC CLEANER Polymer Technology Corp. LPN Class II 1997-11-24
K973193 LUXSCOPE Luxtec Corp. HQF Class II 1997-11-21
K973192 FLEXLENS, FLEXLENS TORIC Specialty Ultravision, Inc. LPL Class II 1997-11-20
K974045 VENNETO Amsure Sports, Inc. HQY Class I 1997-11-20
K973597 AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS Martin Dalsing LPL Class II 1997-11-20
K973934 SUNGLASSES Elegance Optical Manufactory, Ltd. HQY Class I 1997-11-18
K973756 EYE SYS VISTA Eyesys Technologies, Inc. HLQ Class I 1997-11-13
K973533 NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) Nidek, Inc. HKI Class II 1997-11-04
K973220 RODENSTOCK LASER SLITLAMP G. Rodenstock Instrumente GmbH HQF Class II 1997-11-04
K973218 NIDEK HANDY Nidek, Inc. HKI Class II 1997-11-04
K972808 HANSATOME MICROKERATOME Chiron Vision Corp. HNO Class I 1997-10-24
K972143 MOA BONE / M-SPHERE Iop, Inc. HPZ Class II 1997-10-16
K973526 SUNGLASSES Pyramid Handbags, Inc. HQY Class I 1997-10-16
K972807 (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI Benz Research and Development Corp. LPL Class II 1997-10-15
K972727 CBALK-1000 BLADE Howard Instruments, Inc. HNO Class I 1997-10-10
K972661 EYE SPHERE, CONFORMERS Gulden Ophthalmics HPZ Class II 1997-10-03
K973294 INNOVATOME MICROKERATOME Innovative Optics, Inc. HNO Class I 1997-10-03
K972514 LASEREX LP1532 PHOTOCOAGULATOR Ellex Medical Pty, Ltd. HQF Class II 1997-10-03
K972506 INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR Infinitech, Inc. HJM Class II 1997-10-01
K973490 SUNGLASSES Tong Yang Optical Co. HQY Class I 1997-09-30
K972693 DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR Deroyal Industries, Inc. HOZ Class II 1997-09-30
K972440 CATARACTSCREENER CT - S Neitz Instruments Company, Ltd. HKI Class II 1997-09-30
K973407 SUNGLASSES (NON-PRESCRIPTION) Pacific Optical Co. , Ltd. HQY Class I 1997-09-30
K972522 ML-DISPOSABLE PAK Med-Logics, Inc. MSR Class II 1997-09-30
K972850 SUNGLASSES Indoptica, S.A. HQY Class I 1997-09-17
K973016 NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS Optimaxx Intl. HQY Class I 1997-09-17
K973063 FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR Aspect Vision Care, Ltd. LPL Class II 1997-08-26
K972717 RUFF WORK EYEGEAR Ruff House, Inc. HQY Class I 1997-08-25
K972443 MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS Menicon U.S.A., Inc. HQD Class II 1997-08-22
K972303 OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS Ocular Sciences Puerto Rico, Inc. LPL Class II 1997-08-20
K971953 CONFOSCAN Tomey Corporation USA HJO Class II 1997-08-14
K972454 OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS Bausch & Lomb, Inc. LPL Class II 1997-08-08
K971853 ENDOVIEW SPPHIRE LENS SET American Medical Devices, Inc. HJK Class II 1997-08-06
K971950 INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER Infinitech, Inc. HQF Class II 1997-08-01
K963744 BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) Benz Research and Development Corp. HQD Class II 1997-07-31
K971832 IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK M-Pact Worldwide Management Corp. HOZ Class II 1997-07-31
K963512 BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL Benz Research and Development Corp. HQD Class II 1997-07-31
K972590 NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES Lbi U.S.A. HQY Class I 1997-07-31
K972252 VISTA UNIVERSAL HANDPIECE Odyssey Technologies, Inc. HQC Class II 1997-07-29
K971671 HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) Heidelberg Engineering HLI Class II 1997-07-29
K972253 P3 UNIVERSAL PHACO HANDPIECE Odyssey Technologies, Inc. HQC Class II 1997-07-29
K972490 D'ARC EYE CARE SUNGLASSES M & R Dist. HQY Class I 1997-07-25
K972416 MOMO DESIGN OR MOMO Momo U.S.A., Inc. HQY Class I 1997-07-21
K970414 CONFOCAL MICROSCOPE Con-S , Ltd. HJO Class II 1997-07-15
K971647 LL BI-FOCAL, DAILY WEAR CONTACT LENS Lombart Lenses, Ltd. LPL Class II 1997-07-15
K971795 AUTOMATED CHAMBER MAINTENANCE MODULE Paradigm Medical Industries, Inc. HQC Class II 1997-07-14
K972362 FOVS, BRILLARTE, ETC... Sunglass City, Inc. HQY Class I 1997-07-14
K971538 MENTOR GEMINI HEMOSTATIC ERASER Mentor Ophthalmics, Inc. HQO Class II 1997-07-14
K971618 ALCON CONTACT LENS CASE Alcon Laboratories LRX Class II 1997-07-14
K971385 SUNGLASSES Kosway Industries Co., Ltd. HQY Class I 1997-07-14
K970327 SCLERAL SHELL Southwest Artificial Eyes, Inc. HQT Class II 1997-07-07
K970320 SCLERAL SHELL Xavier A. Guerra, Ocularist, Inc. HQT Class II 1997-07-07
K970319 OCULAR CONFORMER Xavier A. Guerra, Ocularist, Inc. HQN Class II 1997-07-07
K970318 OCULAR CONFORMER Southwest Artificial Eyes, Inc. HQN Class II 1997-07-07
K962767 MS401097-17,MS722-K,MS720,MS721,MS722 Alexander Mfg. Co. HLJ Class II 1997-07-03
K971462 SUNGLASSES D.G. Prove Co. HQY Class I 1997-07-01
K971384 (BRAND NAME) Long IN Time Ent. Co., Ltd. HQY Class I 1997-07-01
K971750 WELCH ALLYN PHACO ILLUMINATOR Welch Allyn, Inc. HQC Class II 1997-06-30
K971583 MEDPOR OCULAR SCREW AND ACCEOSSORIES Porex Technologies Corp. MQU Class II 1997-06-30
K972246 SPECTACLE FRAMES (NON-PRESCRIPTION) Alimar Trading, Inc. HQY Class I 1997-06-26
K971685 IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM Tomey Corporation USA HKI Class II 1997-06-24

4,756 clearances in the Ophthalmic panel. Data: openFDA.