meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
40
Latest Decision
1993-03-19

Clearances · page 31 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K922370 NEW EDITIONS CHILDRENS SUNGLASSES Fishel Toys , Ltd. HQY Class I 1993-03-19
K923725 OPHTHALMIC PHARCO NEEDLE Synergetics, Inc. HQC Class II 1993-03-18
K923884 AUGUSTA VALENTINI Revue Intl. HQZ Class I 1993-03-18
K924032 CORNEAL ANALYSIS SYSTEMS(TM) Eyesys Laboratories, Inc. HQY Class I 1993-03-18
K923816 CONTACT LENS CLEANING ACCESSORY Cramer Ent., Inc. LYL Class II 1993-03-08
K923958 CHROMOS IMAGER Chromos Imaging, Inc. HKI Class II 1993-03-04
K923500 BEAUSOLEIL FRAME Oliver Peoples, Inc. HQZ Class I 1993-02-16
K923435 CORNEAL TOPOGRAPHY SYSTEM Par Microsystems Corp. HLQ Class I 1993-02-16
K914618 SUNGLASSES La Salle Imports, Inc. HQY Class I 1993-02-16
K924090 THE ENDO OPTIKS MICROPROBE Endo Optics, Inc. HQB Class II 1993-02-01
K922294 PERIKON PCL 90 Optikon Oftalmologia Spa HPT Class I 1993-01-28
K924787 BURTON SLIT LAMP R.H. Burton Co. HJO Class II 1993-01-27
K924782 BURTON SLIT LAMP - MODEL 2000 R.H. Burton Co. HJO Class II 1993-01-27
K924770 BURTON HAND HELD SLIT LAMP - MODEL SL750 R.H. Burton Co. HJO Class II 1993-01-27
K924222 MID LABS, INC. VIT MATE Medical Instrument Development Laboratories, Inc. HQE Class II 1993-01-27
K922464 SUNGLASSES Wing Shing Optical Manufacturers , Ltd. HQY Class I 1993-01-27
K925254 AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 Allergan Medical Optics HQC Class II 1993-01-07
K923438 BOSTON CONDITIONING SOLUTION Polymer Technology Corp. LPN Class II 1992-12-28
K924999 AUTOPOLE REGULATOR SYSTEM Escalon Trek Medical KYG Class I 1992-12-24
K921632 INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASK Lawrence Technologies, Inc. HQZ Class I 1992-12-23
K924052 INFINITY MICRO IRRIGATOR Infinity Surgical Technology, Inc. KYG Class I 1992-12-23
K924235 AMO ELITE Allergan Medical Optics HQC Class II 1992-12-23
K924753 BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE Bioenterics Corp. HMJ Class I 1992-12-15
K922378 OPHTHALMIC KNIFE Microptics Development Laboratory HNN Class I 1992-12-10
K924604 STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV Storz Instrument Co. HQE Class II 1992-11-27
K924198 MODIFIED SITE FIBER OPTIC MODULE Chiron Vision Corp. FCT Class II 1992-11-23
K920672 SUNGLASSES, NON PRESCRIPTION Daystone Intl. Corp. HQY Class I 1992-11-23
K921414 TROKEL /3 GONIO LASER LENS Ocular Instruments, Inc. LQJ Class II 1992-11-16
K923670 BYRNE EXPULSIVE LENS Ocular Instruments, Inc. HJI Class I 1992-11-16
K924232 SPECTACLE FRAMES Aptaker Co., Inc. HQZ Class I 1992-11-05
K921615 LENSONIC(TM) CONTACT LENS CARE ACCESSORY Personal Professional Products, Inc. LYL Class II 1992-11-05
K924033 ALTEX MODEL UST-3000E Optro-Mechanics (Usa) Corp. HQC Class II 1992-11-05
K923437 BOSTON CLEANER II Polymer Technology Corp. LPN Class II 1992-10-28
K921163 REGALTECH MAXISCOPE Regaltech Pty. , Ltd. HLI Class II 1992-10-27
K923629 OPHTHALMIC TRICHIASIS PROBE Mira, Inc. HPS Class II 1992-10-19
K923415 DBA FOCAL CHANGE FRAMES Focal Change HQZ Class I 1992-10-13
K920937 COMPUTERIZED PUPIL Trek Medical Products, Inc. HLG Class I 1992-10-02
K923877 TONOSHIELD TONOMETER SHIELD Oasis Medical, Inc. HKY Class II 1992-09-30
K922242 910T MONTORIZED INSTRUMENT TABLE R.H. Burton Co. HRJ Class I 1992-09-30
K922910 MEDICAL BATTERY PACKS Access / God Loves You HLJ Class II 1992-09-30
K922930 OPTICAL FRAMES St. Germain Eyewear Intl. HQZ Class I 1992-09-17
K921685 SOLAZ Solarchromic, Inc. HQY Class I 1992-09-02
K923167 THE NISSEL ARTIFICIAL EYE Nissel , Ltd. HQH Class I 1992-09-02
K915266 VISOR SUNGLASSES/LENS/NOVELTY VISOR Janlin Ent. HQY Class I 1992-09-02
K922258 SPECTACLE FRAMES British Optical Import Co. HQZ Class I 1992-09-02
K922687 OPTHALMIC FRAMES Optique Forte , Ltd. HQZ Class I 1992-08-31
K922595 MODIFIED SITE MACROBORE PHACO NEEDLE Chiron Vision Corp. HQC Class II 1992-08-31
K922508 RUBBER FRAME SUNGLASSES Jedda Dist., Inc. HQY Class I 1992-08-26
K921882 THE CLEANER ACCESSORY Eaton Medical Corp. LYL Class II 1992-08-25
K922355 POLLY'S VITREOUS SCISSORS J-225-S O.R. Specialties, Inc. HQE Class II 1992-08-18
K914473 SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES Biomedical Optics Co. of America, Inc. HQY Class I 1992-08-05
K921617 CYLINDER OF GAS, CAN OF GAS (CC12F2) Bio-Rad HKX Class II 1992-08-05
K920354 OPHTHALMIC SPONGES Ultracell Medical Technologies, Inc. HOZ Class II 1992-08-05
K920861 WOODLYN CLASSIC LENSMETER Woodlyn, Inc. HLM Class I 1992-07-30
K922001 SPECTACLE FRAMES Otego Optical, Inc. HQZ Class I 1992-07-28
K922996 MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS Chiron Vision Corp. KYG Class I 1992-07-27
K920836 SUNGLASSES A Toz Importing Co. HQY Class I 1992-07-27
K923177 OPTICAL FRAMES A Toz Importing Co. HQZ Class I 1992-07-27
K922121 SUNGLASSES Pavilion Investment , Ltd. HQY Class I 1992-07-21
K921221 STERILE/SINGLE USE SYMBLEPHARON RING Storz Instrument Co. HQN Class II 1992-07-17
K921758 STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM Storz Instrument Co. HQE Class II 1992-07-16
K921815 TOMEY PE-300 PORTABLE ERG Tomey Corporation USA HLT Class II 1992-07-15
K920795 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX Optical Radiation Corp. HQG Class I 1992-07-13
K921444 DIGI SPORTLENS SYSTEM Fitness Quest, Inc. HQY Class I 1992-07-13
K920701 INDUSTRIAL STRENGTH EYEWEAR Grafix Marketing Group HQY Class I 1992-07-13
K920272 ORIEL Truphatek, Ltd. HLJ Class II 1992-07-09
K922735 ZIESS ENDOPROBE Carl Zeiss, Inc. HQB Class II 1992-07-09
K922180 LEWICKY O.R.S. TUBING O.R. Specialties, Inc. KYG Class I 1992-07-02
K921460 STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS Storz Instrument Co. HQE Class II 1992-07-02
K920807 SUNGLASSES Libby Lee Toys, Inc. HQY Class I 1992-07-01
K921607 IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE Chiron Vision Corp. HQC Class II 1992-06-30
K920764 SUNGLASSES AND EYEGLASS FRAMES New Optic Srl HQY Class I 1992-06-25
K914416 BREATH-EASY, MODIFICATION Icor AB HME Class I 1992-06-23
K922253 KERATOREF L60 Luneau Ophtalmologie SA HLQ Class I 1992-06-19
K921214 OPHTHALMIC PROJECTOR Luneau Ophtalmologie SA HOS Class I 1992-06-11
K912904 MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM Mentor O & O, Inc. HQC Class II 1992-06-11
K921229 STERILE/SINGLE USE OPHTHALMIC CONFORMERS Storz Instrument Co. HQN Class II 1992-06-09
K921135 IOLAB POWER I.V. POLE Site Microsurgical Systems, Inc. HQC Class II 1992-06-03
K920718 DISPOSABLE POSTERIOR MICROSCISSORS Storz Instrument Co. HQE Class II 1992-05-18
K920582 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. Site Microsurgical Systems, Inc. HQE Class II 1992-05-08
K921488 ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION Surgical Technologies, Inc. HMX Class I 1992-05-07
K920571 TRIAL LENS SET R.H. Burton Co. HPC Class I 1992-05-07
K920211 SUN/SPORTGLASSES Bacou USA, Inc. and Uvex Safety, Inc. HQY Class I 1992-05-01
K920169 SUNGLASSES Walgreen Co. HQY Class I 1992-05-01
K920271 WEINSTEIN CORNEAL MIRCOAESTHESIOMETER Connecticut Bioinstruments, Inc. HJC Class I 1992-04-21
K920344 SUNGLASSES J & D Products, Inc. HQY Class I 1992-04-21
K920181 OPTICAL FRAME A285, A210, B220, A215, A255, B220, Kentucky Optical Co. HQZ Class I 1992-04-15
K914975 CABLE CAR SUNGLASSES Cable Car Sunglasses HQZ Class I 1992-03-31
K915340 MENTOR HORIZON LOW VISION MAGNIFIER Mentor O & O, Inc. HJG Class I 1992-03-30
K921106 STERILE/SINGLE USE EYE SPHERE IMPLANTS Storz Instrument Co. HPZ Class II 1992-03-30
K915263 SUNGLASSES/READING GLASSES Royalking Industrial Corp. HQY Class I 1992-03-25
K915808 AQUEOUS PARACENTESIS PIPET Visitec Co. KYG Class I 1992-03-19
K915605 SUNGLASSES/READING GLASSES Royal Shine Enterprises, Ltd. HQY Class I 1992-03-18
K915661 TECHNA SUN LENS Techna Intl. HQY Class I 1992-03-18
K915745 D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE Storz Instrument Co. HQE Class II 1992-03-13
K920037 OSTEO COMPRESSION HIP SCREW Osteo AG HRC Class II 1992-03-11
K920170 SPECTACLE FRAME Sciara Intl., Inc. HQZ Class I 1992-03-11
K920123 SPECTACLE FRAMES Po-Le Optiks HQZ Class I 1992-03-06
K915861 MEDILENS-CS CORNEAL SHIELD Chiron Ophthalmics MOE Class I 1992-03-06
K920064 OPTI-LENS CONTACT LENS CASE Ryder Intl. Corp. LRX Class II 1992-03-04

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