Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 29
- Latest Decision
- 1997-06-24
Clearances · page 20 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K972014 | SUNGLASSES (NON-PRESCRIPTION) | Tamfort, Ltd. | HQY | Class I | 1997-06-24 |
| K972194 | RIVIERA SUNGLASS4ES | Riviera Optical Co., Ltd. | HQY | Class I | 1997-06-24 |
| K971644 | CEBE | Suunto USA | HQY | Class I | 1997-06-24 |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | Ipax, Inc. | MML | Class II | 1997-06-20 |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | Storz Instrument Co. | HQC | Class II | 1997-06-17 |
| K970887 | BLOOD FLOW ANALYZER | Paradigm Medical Industries, Inc. | HKY | Class II | 1997-06-17 |
| K971087 | SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) | W.J. Byrnes & Co. of Los Angeles, Inc. | HQY | Class I | 1997-06-13 |
| K971707 | SUNGLASSES (NON-PRESCRIPTION) | Niko Sunglasses Corp. | HQY | Class I | 1997-06-13 |
| K971875 | OPTIM-EYES 450 | Taylor/Fox Enterprises, LLC | HQY | Class I | 1997-06-13 |
| K971186 | AMO DIPLOMAX/OPSYS CONSOLE | Allergan, Inc. | HQC | Class II | 1997-06-13 |
| K971064 | BAYERS BIMANUAL I/A HANDPIECES | Visioncare Devices, Inc. | HQC | Class II | 1997-06-09 |
| K970816 | GLARE WARE | Ergovision, Inc. | HQY | Class I | 1997-06-05 |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | HOY | Class I | 1997-06-04 |
| K971551 | DUQIAO | Duqiao Glasses (Group) Co. , Ltd. | HQY | Class I | 1997-06-04 |
| K971495 | PATHFINDER SUNGLASSES | Coil | HQY | Class I | 1997-05-29 |
| K971156 | KASHA VISUAL FIELD SYSTEM | Kasha Software, Inc. | HPT | Class I | 1997-05-28 |
| K971173 | ML DISPOSABLE ALK TUBING | Med-Logics, Inc. | KYG | Class I | 1997-05-22 |
| K971049 | FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Aspect Vision Care, Ltd. | LPL | Class II | 1997-05-21 |
| K971164 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | Aspect Vision Care, Ltd. | LPL | Class II | 1997-05-21 |
| K971515 | PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK) | Biomed Devices Corp. | LPL | Class II | 1997-05-20 |
| K964702 | EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 | Euclid Systems Corp. | MMQ | Class I | 1997-05-20 |
| K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | American Medical Devices, Inc. | HMX | Class I | 1997-05-20 |
| K965052 | D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES | Wesley Jessen Corp. | LPL | Class II | 1997-05-14 |
| K971412 | SUNGLASSES | Team Chien Industrial Co., Ltd. | HQY | Class I | 1997-05-13 |
| K970699 | AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES | Yeong Jiuh Corp. | HQY | Class I | 1997-05-13 |
| K970746 | SEE3 (LOTRAFILCON A) SOFT CONTACT LENS | Ciba Vision Corporation | LPL | Class II | 1997-05-09 |
| K971327 | UNIKA | Eyewear Partners Co. | HQY | Class I | 1997-05-09 |
| K961805 | TOMEY DTL ELECTRODE | Tomey Corporation USA | HLZ | Class II | 1997-05-09 |
| K970698 | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS | Polymer Technology Corp. | HQD | Class II | 1997-05-06 |
| K970476 | HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION) | Hwa Mao Optical Co., Ltd. | HQY | Class I | 1997-05-06 |
| K971326 | ARROW COMPANY | Excel Eyewear Corp. | HQY | Class I | 1997-05-06 |
| K970759 | SOLAR SPECS | Morris Rosenbloom & Co., Inc. | HQY | Class I | 1997-05-06 |
| K971249 | GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN | Andrew G. Halpern | HQY | Class I | 1997-05-06 |
| K971104 | CLASSIC MATCH | Delagar Division Belcam, Inc. | HQY | Class I | 1997-05-06 |
| K970315 | EVEREST SUNGLASSES | Ycc International Corp. | HQY | Class I | 1997-05-06 |
| K970670 | REUSABLE VITRECTOMY PROBE | Altex Vision | HQE | Class II | 1997-05-06 |
| K970895 | CUSTOM OPTICAL SUNGLASS FRAMES | Custom Optical Frames, Inc. | HQY | Class I | 1997-05-06 |
| K970454 | LAXIMA INTERNATIONAL LIMITED SUNGLASSES | Laxima Intl., Ltd. | HQY | Class I | 1997-05-06 |
| K970944 | BARAKKA, INFERNO, STERLING, AND/OR ONE | Sentinal Importing Corp. | HQY | Class I | 1997-05-06 |
| K971108 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P | Alexander Mfg. Co. | MSG | Class II | 1997-05-06 |
| K970673 | DISPOSABLE VITRECTOMY PROBE | Altex Vision | HQE | Class II | 1997-05-05 |
| K970033 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | KYB | Class I | 1997-04-23 |
| K970095 | PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS | Biocompatibles Eyewear, Inc. | LPL | Class II | 1997-04-03 |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | HLJ | Class II | 1997-04-02 |
| K970312 | CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) | Flexlens, Inc. | LPL | Class II | 1997-04-02 |
| K970377 | PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) | Plancon Instruments | HNO | Class I | 1997-03-31 |
| K965185 | ACRYPAK FOLDER | Alcon Laboratories | KYB | Class I | 1997-03-31 |
| K970744 | STYLE EYES OPTICS | Anti-Ray, Inc. | HQY | Class I | 1997-03-31 |
| K970268 | ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY | Alexander Mfg. Co. | MSG | Class II | 1997-03-31 |
| K964891 | ORBSHOT KERATOMETER | Orbtek, Inc. | MMQ | Class I | 1997-03-26 |
| K970161 | HEDGES CORNEAL WETTING PAK | Hedges Cwp, Inc. | KYG | Class I | 1997-03-25 |
| K970019 | MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS | Menicon U.S.A., Inc. | LPL | Class II | 1997-03-25 |
| K970538 | VICTORY EYEWEAR CO | Victory Eyewear Co., Ltd. | HQY | Class I | 1997-03-25 |
| K965125 | DAKOTA SMITH, NICOLE MILLER SUNGLASSES | California Design Studio, Inc. | HQY | Class I | 1997-03-19 |
| K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | Mira, Inc. | HLI | Class II | 1997-03-19 |
| K970615 | PROMED 55-G SOFT DAILY WEAR CONTACT LENS | Biomed Devices Corp. | LPL | Class II | 1997-03-19 |
| K952558 | AARON VAC 2 | Aaron Medical Industries | HKP | Class II | 1997-03-19 |
| K965127 | DGH MODEL 9000 | Dgh Technology, Inc. | HQC | Class II | 1997-03-17 |
| K964902 | CONTACT LENSES METRO-G 3X (HIOXIFILCON B) | Metro Optics of Austin, Inc. | LPL | Class II | 1997-03-11 |
| K965170 | ROCCOBAROCCO & PRO-DYNAMIX | Michelangelo, Inc. | HQY | Class I | 1997-03-11 |
| K965012 | LIFESTYLE BREAK THRU (POLYMACON) | The Lifestyle Co., Inc. | LPL | Class II | 1997-03-11 |
| K963001 | LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Permeable Technologies, Inc. | LPL | Class II | 1997-03-11 |
| K964528 | (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT | Benz Research and Development Corp. | LPL | Class II | 1997-03-07 |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | Shippert Medical Technologies Corp. | HOZ | Class II | 1997-03-04 |
| K970101 | JAMES ALEX SUNGLASSES | D&K Stores, Inc. | HQY | Class I | 1997-03-04 |
| K963079 | CANON TX-10 TONOMETER | Canon USA, Inc. | HKX | Class II | 1997-03-03 |
| K964018 | PHACOILLUMINATOR - FIBEROPTIC SLEEVE | Michael Reynard, M.D. | HQC | Class II | 1997-02-26 |
| K965021 | NON-PRESCRIPTION SUNGLASSES | Victory Eyewear Co., Ltd. | HQY | Class I | 1997-02-25 |
| K964943 | SUNGLASSES (NON-PRESCRIPTION) | Micron Eyewear Manufactory Co., Ltd. | HQY | Class I | 1997-02-25 |
| K964751 | CERALAS DIODE LASER SYSTEM (CERALAS D2) | Ceram Optec, Inc. | HQF | Class II | 1997-02-21 |
| K964696 | SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS | Sunsoft Corp. | LPL | Class II | 1997-02-20 |
| K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | Pharmacia Iovision, Inc. | KYF | Class II | 1997-02-18 |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Storz Instrument Co. | HQE | Class II | 1997-02-03 |
| K964137 | RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | HLI | Class II | 1997-02-03 |
| K964612 | VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT | Vistakon, Johnson & Johnson Vision Products, Inc. | LPL | Class II | 1997-01-30 |
| K963764 | SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR | Specialty Ultravision, Inc. | LPL | Class II | 1997-01-30 |
| K964366 | EAGLE EYES | Mech-Tronic Precision Mfg., Ltd. | HQY | Class I | 1997-01-29 |
| K964564 | SUNGLASSES | Micron Metal & Plastic Manufactory Co. | HQY | Class I | 1997-01-29 |
| K964744 | SENNA | Trans-America Enterprises Corp. | HQY | Class I | 1997-01-29 |
| K964380 | LC-250 INFRARED LIGHT COAGULATOR | Nk-Optik America | HQB | Class II | 1997-01-22 |
| K964505 | GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES | I C Optics, Ltd. | HQY | Class I | 1997-01-10 |
| K962989 | AMOILS EPITHELIAL SCRUBBER | S. Percy Amoils | HOG | Class I | 1997-01-09 |
| K964338 | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT | Rudolf Riester GmbH & Co. KG | HKM | Class I | 1997-01-09 |
| K964290 | EYECHEK | Reichert Ophthalmic Instruments, Div. Leica, Inc. | HLQ | Class I | 1997-01-09 |
| K963762 | CORNEAL TOPOGRAPHER 200 | Eclipse Ventures | MMQ | Class I | 1996-12-23 |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Paladin Medical, Inc. | LYL | Class II | 1996-12-20 |
| K963837 | HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN | Westcon Contact Lens Co., Inc. | LPL | Class II | 1996-12-20 |
| K964289 | EYE FIXATION SPECULUM | Eyefix, Inc. | HNC | Class I | 1996-12-17 |
| K964316 | PLASTIC SUNGLASSES | Medical Reports Exchange, Inc. | HQY | Class I | 1996-12-17 |
| K962185 | HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS | CooperVision, Inc. | LPL | Class II | 1996-12-17 |
| K964429 | SUNGLASSES OR MULTIPLE | Trade Resources , Ltd. | HQY | Class I | 1996-12-12 |
| K962661 | ML MICROKERATOME BLADE | Med-Logics, Inc. | HNO | Class I | 1996-12-09 |
| K962911 | CONTACT LENS WITH COLOR ADDITIVE | Cal Bionics | LPL | Class II | 1996-11-29 |
| K962112 | NEW COMFORT CONTACT LENS CARE ACCESSORY | Lens Comfort, Inc. | LYL | Class II | 1996-11-29 |
| K963011 | LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Permeable Technologies, Inc. | LPL | Class II | 1996-11-29 |
| K963487 | DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS | Ciba Vision Corporation | LPL | Class II | 1996-11-27 |
| K964312 | MENTOR TONO-PEN 3 | Mentor Ophthalmics, Inc. | HKY | Class II | 1996-11-26 |
| K961738 | VIT COMMANDER SYSTEM | Scieran Technologies, Inc. | HQE | Class II | 1996-11-25 |
| K964413 | SUNGLASSES(NON-PRESCRIPTION) | Ever Prime Enterprises , Ltd. | HQY | Class I | 1996-11-25 |
| K964058 | SPENSER SUNGLASSES AND SPORT SUNGLASSES | Spencer Products Co. | HQY | Class I | 1996-11-25 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.