Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 16
- Latest Decision
- 1994-06-23
Clearances · page 27 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K942365 | BOSTON VII | Polymer Technology Corp. | HQD | Class II | 1994-06-23 |
| K941463 | SPECTACLE FRAMES, READING GLASSES | Well Arts Optical Factory , Ltd. | HQZ | Class I | 1994-06-17 |
| K940733 | SPECTACLE FRAMES (V.I.P. INT'L) | Continental Optical Imports | HQZ | Class I | 1994-06-17 |
| K940084 | MODEL 2000 OPHTHALMIC SURGICAL SYSTEM | Medical Technical Products | HQC | Class II | 1994-06-17 |
| K940923 | SUNGLASSES | Gbs Corp. | HQY | Class I | 1994-06-17 |
| K941211 | SPECTACLE FRAMES | H & M Optical (U.S.A.) , Ltd. | HQZ | Class I | 1994-06-17 |
| K941061 | SUNGLASSES | Kingmart Trading Co., Ltd. | HQY | Class I | 1994-06-17 |
| K941877 | LL-55 (METHAFILCON A) FOR DAILY WEAR | Lombart Lenses, Ltd. | LPL | Class II | 1994-06-14 |
| K931792 | ARTHROSCOPE | Intramed Laboratories, Inc. | HRH | Class I | 1994-06-13 |
| K941484 | DAILY WEAR SOFT CONTACT LENSES | Ciba Vision Corporation | LPL | Class II | 1994-06-09 |
| K940391 | PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE | Peregrine Surgical , Ltd. | HQE | Class II | 1994-06-08 |
| K940974 | EYECLOSE EXTERNAL EYELID WEIGHTS | Meddev Corp. | MML | Class II | 1994-06-08 |
| K941723 | WELCH ALLYN GLAUCOMA DETECTOR | Welch Allyn, Inc. | HOO | Class I | 1994-06-06 |
| K940659 | SUNGLASSES | Leonardo, Inc. | HQY | Class I | 1994-06-06 |
| K941607 | UCL MULTIFOCAL SOFT CONTACT LENS | United Contact Lens, Inc. | LPL | Class II | 1994-06-06 |
| K941432 | NON-PRESCRIPTION SUNGLASSES | Large River Industrial Co., Ltd. | HQY | Class I | 1994-06-06 |
| K940746 | VIT CUTTER MODEL 94 | Visioncare Devices, Inc. | HQE | Class II | 1994-06-06 |
| K941687 | CHILDREN'S SUNGLASSES | Merchandising/Imports | HQY | Class I | 1994-06-06 |
| K942407 | AMCON SLIP IN MYDRIATIC SUNGLASSES | Amcon Laboratories, Inc. | HOY | Class I | 1994-06-06 |
| K942237 | SUNGLASSES | Sun Wellen, Inc. | HQY | Class I | 1994-06-06 |
| K941119 | XIAMEN DYNASTY OPTICAL CORP | Xiamen Dynasty Optical Corp. , Ltd. | HQY | Class I | 1994-06-06 |
| K940740 | SKI VECTOR NON PRECRIPTION SUNGLASSES | Mountain Shades, Inc. | HQY | Class I | 1994-06-03 |
| K940850 | SUNGLASSES (NON-PRESCRIPTION) | Fantasia Novelty Ent. Corp. | HQY | Class I | 1994-06-03 |
| K934576 | SUNGLASSES | Guide Firm , Ltd. | HQY | Class I | 1994-06-03 |
| K940947 | CROWN,SKI OPTIC SUNGLASSES | Sunglass Experts | HQY | Class I | 1994-06-03 |
| K941602 | SPECTACLE FRAMES | Slim Occhiali | HQZ | Class I | 1994-06-03 |
| K941873 | SUNGLASSES | Koadak Optical Industrial Co., Ltd. | HQY | Class I | 1994-06-03 |
| K941296 | SUNGLASSES | Three Leaves Industrial Co., Ltd. | HQY | Class I | 1994-06-03 |
| K942034 | R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 | R & D Batteries, Inc. | HLJ | Class II | 1994-06-03 |
| K932669 | SUPRA-VIT(TM) | Medical Instrument Development Laboratories, Inc. | HQE | Class II | 1994-06-03 |
| K940831 | SKI VECTOR NON-PRESCRIPTION SUNGLASSES | Mountain Shades, Inc. | HQY | Class I | 1994-06-03 |
| K942375 | SUNGLASSES | Kool World, Inc. | HQY | Class I | 1994-06-03 |
| K941576 | SPECTACLE FRAMES/SUNGLASSES | Sanders Optical Co., Inc. | HQY | Class I | 1994-06-03 |
| K941767 | FRAMES - VARIOUS BRAND NAMES | Lenscraft, Inc. | HQZ | Class I | 1994-06-03 |
| K941751 | SUNGLASSES | The Orvis Co., Inc. | HQY | Class I | 1994-06-03 |
| K941875 | SUNGLASSES | The Limited Stores, Inc. | HQY | Class I | 1994-06-03 |
| K940741 | MOUNTAIN SHADES -NONPRESCRIPTION SUNGLASSES | Mountain Shades, Inc. | HQY | Class I | 1994-06-03 |
| K941370 | BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | LPL | Class II | 1994-05-27 |
| K940958 | NON-PRESCRIPTION SUNGLASSES | Great Future Works , Ltd. | HQY | Class I | 1994-05-18 |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | Visitec Co. | HJM | Class II | 1994-05-17 |
| K940504 | SPECTACLE FRAMES | Tecnol-Tecnica Nacional DE Oculos Ltda | HQZ | Class I | 1994-05-17 |
| K940945 | SUNGLASSES | Hi-Shine Ent. Co., Ltd. | HQY | Class I | 1994-05-17 |
| K941410 | CHIN HSIEU CHENG | Large River Industrial Co., Ltd. | HQY | Class I | 1994-05-17 |
| K941369 | AVON CAT SUNGLASSES | Siegel,Mandell & Davidson,P.C. | HQY | Class I | 1994-05-17 |
| K934659 | SUNGLASS | South American Plastic Manufactory Co. , Ltd. | HQY | Class I | 1994-05-17 |
| K941829 | SUN FILTERS/SHIELDS | Klinger Eye Shields, Inc. | HOY | Class I | 1994-05-17 |
| K935422 | SUNLOVERS, CHARLES JOURDAN, COURREGES SUNGLASSES | Sunlovers Sunglasses | HQY | Class I | 1994-05-17 |
| K941338 | CHANG CHENG CHUNG | Designer Brass Corp. | HQY | Class I | 1994-05-17 |
| K941590 | SUNGLASSES | Avon Products, Inc. | HQY | Class I | 1994-05-17 |
| K940311 | SUNGLASSES AND SPORT SUNGLASSES | Lanner Enterprise Co., Ltd. | HQY | Class I | 1994-05-17 |
| K941668 | SUNGLASSES | Yon'S Jay Enterprise Co., Ltd. | HQY | Class I | 1994-05-17 |
| K941682 | COOL KIDS BEADS AND SHADES | Ja-Ru, Inc. | HQY | Class I | 1994-05-17 |
| K941523 | SPECTACLE FRAMES | Amore Mio, Inc. | HQZ | Class I | 1994-05-17 |
| K941786 | SUNGLASSES | Modo Eyewear USA | HQY | Class I | 1994-05-17 |
| K941502 | SUNGLASSES | Asia Pacific Trading Co., Inc. | HQY | Class I | 1994-05-17 |
| K941629 | SUNGLASSES | Kuang Yauh Optical Co., Ltd. | HQY | Class I | 1994-05-17 |
| K940609 | TOUCH CORP | Touch Corp. | HQY | Class I | 1994-05-17 |
| K941340 | BORRION ENTERPRISE CO | Borrion Enterprise Co. | HQY | Class I | 1994-05-17 |
| K940943 | SUNGLASSES | Kendward Industrial Corp. | HQY | Class I | 1994-05-17 |
| K941732 | SUNGLASSES | Pacific Eyes & T'S | HQY | Class I | 1994-05-17 |
| K941638 | SUNGLASSES | Sun Coast Merchandise Corp. | HQY | Class I | 1994-05-17 |
| K941307 | SPECTACLE FRAMES | Eyemart Express, Inc. | HQZ | Class I | 1994-05-17 |
| K940705 | 86 HQY SUNGLASSES | Firestar, Inc. | HQY | Class I | 1994-05-17 |
| K941060 | ALPINA EYEWEAR | Alpina High Tech Sports Eyewear | HQY | Class I | 1994-05-17 |
| K940728 | NONE-GENERIC | Dyer Intl. | HQY | Class I | 1994-05-17 |
| K941380 | SUNGLASSES | Spare Parts Accessories | HQY | Class I | 1994-05-17 |
| K941280 | SUNGLASSES (NON PRESCRIPTION) | Autotime Industry, Inc. | HQY | Class I | 1994-05-17 |
| K941930 | SUNGLASSES | Sunvista Import, Inc. | HQY | Class I | 1994-05-17 |
| K941186 | NON-PRESCRIPTION SUNGLASSES | Sungold Ent. , Ltd. | HQY | Class I | 1994-05-17 |
| K941035 | VENOSCOPE | Trinity Partners, LLC | HJN | Class I | 1994-05-16 |
| K941415 | FITIPALDI DRIVING SUNGLASSES | L'Equipe Visual, Inc. | HQY | Class I | 1994-05-09 |
| K941442 | I CARE | I Care Intl., Inc. | HQY | Class I | 1994-05-09 |
| K941680 | SUNGLASSES | Walmart Stores | HQY | Class I | 1994-05-09 |
| K941529 | SUNGLASSES | Wesearch, Inc. | HQY | Class I | 1994-05-09 |
| K940277 | PAFLUFOCON A, B, C & D | Paragon Vision Sciences | HQD | Class II | 1994-05-09 |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | Oculo Plastik, Inc. | HPZ | Class II | 1994-05-05 |
| K930842 | THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE | Grieshaber & Co. | HQE | Class II | 1994-05-03 |
| K941138 | SG-22 SUNGLASSES | American Bestin Mfg., Inc. | HQY | Class I | 1994-04-29 |
| K930347 | SHAIDS PROTECTIVE GLASSES | Depuy, Inc. | HOY | Class I | 1994-04-29 |
| K935037 | NON-PRESCRIPTION SUNGLASSES | Xiamen Chenyi Plastics Industrial Co. , Ltd. | HQY | Class I | 1994-04-29 |
| K936103 | CROWN SUNGLASSES | Capo, Inc. | HQY | Class I | 1994-04-29 |
| K941695 | SUNGLASSES | Sun Creations, Inc. | HQY | Class I | 1994-04-29 |
| K941077 | SUNGLASSES | Kingsun Optical Ent. Co., Ltd. | HQY | Class I | 1994-04-29 |
| K941297 | YUNG HSU OPTICAL WORKS CO | Yung Hsu Optical Works Co. | HQY | Class I | 1994-04-29 |
| K940977 | SPECTACLE FRAMES | Super Optical, Inc. | HQZ | Class I | 1994-04-29 |
| K940990 | SUNGLASSES | Jpreynolds Co., Inc. | HQY | Class I | 1994-04-29 |
| K940946 | GUANGZHOU DASHIN OPTICS ENT. | Guangzhou Dashin Optics Enterprise , Ltd. | HQY | Class I | 1994-04-25 |
| K934844 | INTER TIP T | Microsurgical Technology, Inc. | HMX | Class I | 1994-04-19 |
| K935952 | ROTA SYSTEM 5000 | Rota Systems Medfurniture, Inc. | HMF | Class I | 1994-04-19 |
| K940250 | NEW EYES EYEGLASS FRAME | Sunrise International Business | HQY | Class I | 1994-04-19 |
| K935945 | ROTA DATAMATE I | Rota Systems,Inc. | HMF | Class I | 1994-04-19 |
| K935943 | KING'S SUNGLASS CORP. | King'S Sunglass Corp. | HQY | Class I | 1994-04-19 |
| K940782 | ARTSUN OPTICAL FRAME | Frontier Novelty, Inc. | HQZ | Class I | 1994-04-12 |
| K940182 | SUNGLASSES | Beta Toys, Inc. | HQY | Class I | 1994-04-12 |
| K932844 | SUNGLASSES | Glascal Industries, Ltd. | HQY | Class I | 1994-04-12 |
| K941055 | NON-PRESCRIPTION SUNGLASSES | Kingsun Optical Ent. Co., Ltd. | HQY | Class I | 1994-04-12 |
| K940777 | BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Unilens Corp., USA | LPL | Class II | 1994-04-12 |
| K940853 | MORRISON FRAME, SPECTACLE | Morrison Center | HQZ | Class I | 1994-04-12 |
| K941147 | SPLASHMASTER OC EYE AND FACE PROTECTIVE PRODUCTS | Cabot Safety Corp. | HQY | Class I | 1994-04-12 |
| K940077 | SPECTACLE FRAMES (WING SHING OPTICAL) | Continental Optical Imports | HQZ | Class I | 1994-04-12 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.