FDA 510(k) Applications for Medical Device Product Code "HQY"
(Sunglasses (Non-Prescription Including Photosensitive))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972246 | ALIMAR TRADING, INC. | SPECTACLE FRAMES (NON-PRESCRIPTION) | 06/26/1997 |
| K954419 | AMI FASHION | SPECTACLE FRAMES/SUNGLASSES | 05/16/1996 |
| K974045 | AMSURE SPORTS, INC. | VENNETO | 11/20/1997 |
| K971249 | ANDREW G. HALPERN | GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN | 05/06/1997 |
| K970744 | ANTI-RAY, INC. | STYLE EYES OPTICS | 03/31/1997 |
| K960573 | ARCHITECTURES | SUNGLASSES/EYEGLASS FRAMES | 03/12/1996 |
| K960530 | ARNET OPTIC ILLUSIONS | ARNET OR ARNETTE | 03/04/1996 |
| K963955 | BERT & JOE'S, INC. | DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS | 11/19/1996 |
| K954659 | BLUBLOCKER CORP. | MOONSHADES SUNGLASSES | 01/11/1996 |
| K955933 | BUFFARD CREATION EURL | BUFFARD CREATION (SUNGLASSES) | 03/04/1996 |
| K963630 | C.O.L.D.A. S.N.C. | C.O.L.D.A. | 10/18/1996 |
| K965125 | CALIFORNIA DESIGN STUDIO, INC. | DAKOTA SMITH, NICOLE MILLER SUNGLASSES | 03/19/1997 |
| K962775 | CANADD TRADING CO. | SUNGLASSES (NON-PRESCRIPTION) | 07/25/1996 |
| K974852 | CHIA HUI SPECTACLES MFG. CORP. | NON-PRESCRIPTION SUNGLASSES | 01/30/1998 |
| K962436 | CHUNGSIN KAU OPTICAL MFY. CO. LTD. | SUNGLASSES | 07/02/1996 |
| K962310 | CLASSIC ELEGANCE INTL., INC. | NON-GENERIC | 07/03/1996 |
| K971495 | COIL | PATHFINDER SUNGLASSES | 05/29/1997 |
| K962478 | CUSTOM OPTICAL FRAMES, INC. | (BRAND NAME) SUNGLASS FRAMES | 07/25/1996 |
| K970895 | CUSTOM OPTICAL FRAMES, INC. | CUSTOM OPTICAL SUNGLASS FRAMES | 05/06/1997 |
| K971462 | D.G. PROVE CO. | SUNGLASSES | 07/01/1997 |
| K960798 | D&K STORES, INC. | D & K SUNGLASSES | 04/24/1996 |
| K960797 | D&K STORES, INC. | D & K SUNGLASSES | 03/12/1996 |
| K970101 | D&K STORES, INC. | JAMES ALEX SUNGLASSES | 03/04/1997 |
| K955695 | DAH SING TRADING CO. | PLASTIC FRAME, METAL FRAME, OPTICAL | 01/29/1996 |
| K971104 | DELAGAR DIVISION BELCAM, INC. | CLASSIC MATCH | 05/06/1997 |
| K955572 | DIAMOND MARK INTERNATIONAL CO., LTD. | SUNGLASSES WITH IMPACT RESISTANT LENSES | 01/11/1996 |
| K961523 | DORDA TOYS | TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES | 05/13/1996 |
| K971551 | DUQIAO GLASSES (GROUP) CO. LTD. | DUQIAO | 06/04/1997 |
| K973934 | ELEGANCE OPTICAL MANUFACTORY, LTD. | SUNGLASSES | 11/18/1997 |
| K970816 | ERGOVISION, INC. | GLARE WARE | 06/05/1997 |
| K961146 | ERICA OPTICAL CO. | SUNGLASSES | 05/31/1996 |
| K961746 | EUROTRENDS EYEWEAR, INC. | CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY | 05/16/1996 |
| K964413 | EVER PRIME ENTERPRISES LTD. | SUNGLASSES(NON-PRESCRIPTION) | 11/25/1996 |
| K960735 | EVERGLORY CREATIONS, INC. | EVERGLORY SUNGLASSES | 05/13/1996 |
| K971326 | EXCEL EYEWEAR CORP. | ARROW COMPANY | 05/06/1997 |
| K971327 | EYEWEAR PARTNERS CO. | UNIKA | 05/09/1997 |
| K960786 | FABRIS LANE INTL., LTD. | FABRIS LAN SUNGLASSES | 03/12/1996 |
| K963075 | FRAMESMART, INC. | FITO DIDO | 08/22/1996 |
| K962912 | FRAMESMART, INC. | MARCELLA CARAN | 08/22/1996 |
| K960950 | FRANCO SORDELLI & C. SNC | FRANCO SORDELLI SUNGLASSES | 04/10/1996 |
| K960953 | GALILEE OPTICS | SUNGLASSES | 05/31/1996 |
| K955611 | GATORZ L.L.C. | KMANZ II | 01/03/1996 |
| K962636 | GAUDI SPA | SUNGLASSES, GAUDI SUN LINE | 07/25/1996 |
| K974441 | HIP SHING FAT CO., LTD. | SUNGLASSES | 01/09/1998 |
| K970476 | HWA MAO OPTICAL CO., LTD. | HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION) | 05/06/1997 |
| K964505 | I C OPTICS, LTD. | GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES | 01/10/1997 |
| K972850 | INDOPTICA, S.A. | SUNGLASSES | 09/17/1997 |
| K961286 | INTL. OPTICAL MFG. CO., LTD. | STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES | 05/16/1996 |
| K961603 | INTROMARK, INC. | SUN CLIP | 05/13/1996 |
| K963890 | ITALIAN EYEWEAR, INC. | VARIOUS SUNGLASSES (NON-PRESCRIPTION) | 11/19/1996 |
| K960289 | JAMES KOREA CO., LTD. | JAMES KOREA OPTICAL FRAMES & SUNGLASSES | 02/16/1996 |
| K962279 | JANE FUI OPTICAL CO., LTD. | ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES | 08/26/1996 |
| K973528 | JEOU JEOU LONG INDUSTRIAL CO., LTD. | SUNGLASSES | 12/08/1997 |
| K971385 | KOSWAY INDUSTRIES CO., LTD. | SUNGLASSES | 07/14/1997 |
| K961034 | KYLIE ENTERPRISE CO. LTD. | SUNGLASSES | 04/24/1996 |
| K960628 | LANARD TOYS, LTD. | LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE ZONE | 03/04/1996 |
| K970454 | LAXIMA INTL., LTD. | LAXIMA INTERNATIONAL LIMITED SUNGLASSES | 05/06/1997 |
| K972590 | LBI U.S.A. | NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES | 07/31/1997 |
| K962107 | LEONACHI, INC. | IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 | 06/20/1996 |
| K971384 | LONG IN TIME ENT. CO., LTD. | (BRAND NAME) | 07/01/1997 |
| K963968 | LOOK STYLE, S.R.L. | FLYWAY | 11/19/1996 |
| K972490 | M & R DIST. | D'ARC EYE CARE SUNGLASSES | 07/25/1997 |
| K964366 | MECH-TRONIC PRECISION MFG.,LTD. | EAGLE EYES | 01/29/1997 |
| K964316 | MEDICAL REPORTS EXCHANGE, INC. | PLASTIC SUNGLASSES | 12/17/1996 |
| K961035 | MI TECHNOLOGIES, INC. | US-HOLO SUNGLASSES | 04/10/1996 |
| K965170 | MICHELANGELO, INC. | ROCCOBAROCCO & PRO-DYNAMIX | 03/11/1997 |
| K964943 | MICRON EYEWEAR MANUFACTORY CO., LTD. | SUNGLASSES (NON-PRESCRIPTION) | 02/25/1997 |
| K964564 | MICRON METAL & PLASTIC MANUFACTORY CO. | SUNGLASSES | 01/29/1997 |
| K962298 | MIRAGE EYEWEAR, INC. | CENTER OPTICAL GLASSES | 07/25/1996 |
| K960668 | MISTRAL OPTICAL | MISTRAL SUNGLASSES | 05/31/1996 |
| K972416 | MOMO U.S.A., INC. | MOMO DESIGN OR MOMO | 07/21/1997 |
| K974414 | MORNING CALM CORP. | MULTI | 12/08/1997 |
| K970759 | MORRIS ROSENBLOOM & CO., INC. | SOLAR SPECS | 05/06/1997 |
| K964082 | NEO VU, INC. | SUNGLASSES | 11/25/1996 |
| K962169 | NIKE, INC. | MAGNETO EYEWEAR | 06/24/1996 |
| K962412 | NIKE, INC. | NIKE V8 AND NIKE V12 | 07/03/1996 |
| K971707 | NIKO SUNGLASSES CORP. | SUNGLASSES (NON-PRESCRIPTION) | 06/13/1997 |
| K961268 | OAKLEY, INC. | OAKLEY, INC SUNGLASSES | 04/24/1996 |
| K973016 | OPTIMAXX INTL. | NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS | 09/17/1997 |
| K960890 | OUTDOOR ACTION WEAR SPECIALTIES | SUNGLASSES OR MULTIPLE | 04/10/1996 |
| K973407 | PACIFIC OPTICAL CO. LTD. | SUNGLASSES (NON-PRESCRIPTION) | 09/30/1997 |
| K963083 | PIAZZA OPTICAL CORP. | LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES | 08/26/1996 |
| K962287 | POSITIVE RESPONSE TELEVISION | EAGLE EYES SUNGLASSES | 08/14/1996 |
| K973526 | PYRAMID HANDBAGS, INC. | SUNGLASSES | 10/16/1997 |
| K963284 | RAVEN EYE, INC. | RAVEN EYE- EYE WEAR (SUNGLASSES) | 08/26/1996 |
| K962940 | RAVEN EYE, INC. | RAVEN EYE, INC.- EYE WEAR | 08/26/1996 |
| K972194 | RIVIERA OPTICAL CO., LTD. | RIVIERA SUNGLASS4ES | 06/24/1997 |
| K961990 | ROKKO STARS CO., LTD. | NON-PRESCRIPTION SUNGLASSES | 06/06/1996 |
| K972717 | RUFF HOUSE, INC. | RUFF WORK EYEGEAR | 08/25/1997 |
| K970944 | SENTINAL IMPORTING CORP. | BARAKKA, INFERNO, STERLING, AND/OR ONE | 05/06/1997 |
| K960650 | SOLOVISION OPTICAL, INC. | NON PRESCRIPTION SUN GLASSES | 03/19/1996 |
| K962725 | SOMA INTERNATIONAL LTD. | SOMA | 07/25/1996 |
| K964058 | SPENCER PRODUCTS CO. | SPENSER SUNGLASSES AND SPORT SUNGLASSES | 11/25/1996 |
| K955539 | STEVEN CHEN | UNISUN | 01/03/1996 |
| K974511 | SUN WORLD INTL., INC. | SUNGLASSES | 01/12/1998 |
| K972362 | SUNGLASS CITY, INC. | FOVS, BRILLARTE, ETC... | 07/14/1997 |
| K963059 | SUNQUEST INTL., INC. | SUNQUEST INTERNATIONAL | 08/23/1996 |
| K971644 | SUUNTO USA | CEBE | 06/24/1997 |
| K974179 | TAIPAN OPTICAL COMPANY LTD. | NON-PRESCRIPTION SUNGLASSES | 12/01/1997 |
| K972014 | TAMFORT, LTD. | SUNGLASSES (NON-PRESCRIPTION) | 06/24/1997 |
| K971875 | TAYLOR/FOX ENTERPRISES, LLC. | OPTIM-EYES 450 | 06/13/1997 |
| K971412 | TEAM CHIEN INDUSTRIAL CO., LTD. | SUNGLASSES | 05/13/1997 |
| K943145 | THE MONTICELLO GROUP, INC. | AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE | 04/29/1996 |
| K973490 | TONG YANG OPTICAL CO. | SUNGLASSES | 09/30/1997 |
| K964429 | TRADE RESOURCES LTD. | SUNGLASSES OR MULTIPLE | 12/12/1996 |
| K964744 | TRANS-AMERICA ENTERPRISES CORP. | SENNA | 01/29/1997 |
| K965021 | VICTORY EYEWEAR CO., LTD. | NON-PRESCRIPTION SUNGLASSES | 02/25/1997 |
| K970538 | VICTORY EYEWEAR CO., LTD. | VICTORY EYEWEAR CO | 03/25/1997 |
| K960818 | VISARD SRL | SUNGLASSES | 05/31/1996 |
| K961117 | VISARD SRL | VISARD SUNGLASSES | 04/24/1996 |
| K961128 | VISION-PRO INDUSTRIAL, LTD. | SUNGLASSES | 04/24/1996 |
| K971087 | W.J. BYRNES & CO. OF LOS ANGELES, INC. | SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) | 06/13/1997 |
| K974861 | WENZHOU HINDAR OPTICAL CO., LTD. | NON-PRESCRIPTION SUNGLASSES | 01/27/1998 |
| K974860 | WENZHOU MING MING OPTICAL CO. , LTD. | NON-PRESCRIPTION SUNGLASSES | 01/30/1998 |
| K962382 | XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. | XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. | 07/25/1996 |
| K970315 | YCC INTERNATIONAL CORP. | EVEREST SUNGLASSES | 05/06/1997 |
| K970699 | YEONG JIUH CORP. | AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES | 05/13/1997 |
| K955287 | YUU YENG ENTERPRISE CO., LTD. | ZONG RONG SUNGLASSES | 01/29/1996 |
| K955441 | ZONG RONG GLASSES LTD. CO. | ZONG RONG SUNGLASSES | 01/29/1996 |
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