Atlas FDA

HQY

646 FDA 510(k) clearances · Product code

64 daysmedian time to decision
207 days90th percentile
646clearances measured

FDA profile

Official device name
Sunglasses (Non-Prescription Including Photosensitive)
Device class
Class I (low risk)
Regulation
21 CFR 886.5850
Medical specialty
Ophthalmic
Adverse events (MAUDE)
1996: 6 · 1997: 14 · 1998: 7 · 1999: 3 · 2000: 1 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NON-PRESCRIPTION SUNGLASSES (K974860)Wenzhou Ming Ming Optical Co. , Ltd.1998-01-30
NON-PRESCRIPTION SUNGLASSES (K974852)Chia Hui Spectacles Mfg. Corp.1998-01-30
NON-PRESCRIPTION SUNGLASSES (K974861)Wenzhou Hindar Optical Co., Ltd.1998-01-27
SUNGLASSES (K974511)Sun World Intl., Inc.1998-01-12
SUNGLASSES (K974441)Hip Shing Fat Co., Ltd.1998-01-09
MULTI (K974414)Morning Calm Corp.1997-12-08
SUNGLASSES (K973528)Jeou Jeou Long Industrial Co., Ltd.1997-12-08
NON-PRESCRIPTION SUNGLASSES (K974179)Taipan Optical Company , Ltd.1997-12-01
VENNETO (K974045)Amsure Sports, Inc.1997-11-20
SUNGLASSES (K973934)Elegance Optical Manufactory, Ltd.1997-11-18
SUNGLASSES (K973526)Pyramid Handbags, Inc.1997-10-16
SUNGLASSES (K973490)Tong Yang Optical Co.1997-09-30
SUNGLASSES (NON-PRESCRIPTION) (K973407)Pacific Optical Co. , Ltd.1997-09-30
NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS (K973016)Optimaxx Intl.1997-09-17
SUNGLASSES (K972850)Indoptica, S.A.1997-09-17
RUFF WORK EYEGEAR (K972717)Ruff House, Inc.1997-08-25
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES (K972590)Lbi U.S.A.1997-07-31
D'ARC EYE CARE SUNGLASSES (K972490)M & R Dist.1997-07-25
MOMO DESIGN OR MOMO (K972416)Momo U.S.A., Inc.1997-07-21
FOVS, BRILLARTE, ETC... (K972362)Sunglass City, Inc.1997-07-14
SUNGLASSES (K971385)Kosway Industries Co., Ltd.1997-07-14
SUNGLASSES (K971462)D.G. Prove Co.1997-07-01
(BRAND NAME) (K971384)Long IN Time Ent. Co., Ltd.1997-07-01
SPECTACLE FRAMES (NON-PRESCRIPTION) (K972246)Alimar Trading, Inc.1997-06-26
SUNGLASSES (NON-PRESCRIPTION) (K972014)Tamfort, Ltd.1997-06-24
RIVIERA SUNGLASS4ES (K972194)Riviera Optical Co., Ltd.1997-06-24
CEBE (K971644)Suunto USA1997-06-24
OPTIM-EYES 450 (K971875)Taylor/Fox Enterprises, LLC1997-06-13
SUNGLASSES (NON-PRESCRIPTION) (K971707)Niko Sunglasses Corp.1997-06-13
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) (K971087)W.J. Byrnes & Co. of Los Angeles, Inc.1997-06-13
GLARE WARE (K970816)Ergovision, Inc.1997-06-05
DUQIAO (K971551)Duqiao Glasses (Group) Co. , Ltd.1997-06-04
PATHFINDER SUNGLASSES (K971495)Coil1997-05-29
SUNGLASSES (K971412)Team Chien Industrial Co., Ltd.1997-05-13
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES (K970699)Yeong Jiuh Corp.1997-05-13
UNIKA (K971327)Eyewear Partners Co.1997-05-09
GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN (K971249)Andrew G. Halpern1997-05-06
ARROW COMPANY (K971326)Excel Eyewear Corp.1997-05-06
SOLAR SPECS (K970759)Morris Rosenbloom & Co., Inc.1997-05-06
CLASSIC MATCH (K971104)Delagar Division Belcam, Inc.1997-05-06
LAXIMA INTERNATIONAL LIMITED SUNGLASSES (K970454)Laxima Intl., Ltd.1997-05-06
CUSTOM OPTICAL SUNGLASS FRAMES (K970895)Custom Optical Frames, Inc.1997-05-06
BARAKKA, INFERNO, STERLING, AND/OR ONE (K970944)Sentinal Importing Corp.1997-05-06
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION) (K970476)Hwa Mao Optical Co., Ltd.1997-05-06
EVEREST SUNGLASSES (K970315)Ycc International Corp.1997-05-06
STYLE EYES OPTICS (K970744)Anti-Ray, Inc.1997-03-31
VICTORY EYEWEAR CO (K970538)Victory Eyewear Co., Ltd.1997-03-25
DAKOTA SMITH, NICOLE MILLER SUNGLASSES (K965125)California Design Studio, Inc.1997-03-19
ROCCOBAROCCO & PRO-DYNAMIX (K965170)Michelangelo, Inc.1997-03-11
JAMES ALEX SUNGLASSES (K970101)D&K Stores, Inc.1997-03-04
NON-PRESCRIPTION SUNGLASSES (K965021)Victory Eyewear Co., Ltd.1997-02-25
SUNGLASSES (NON-PRESCRIPTION) (K964943)Micron Eyewear Manufactory Co., Ltd.1997-02-25
EAGLE EYES (K964366)Mech-Tronic Precision Mfg., Ltd.1997-01-29
SENNA (K964744)Trans-America Enterprises Corp.1997-01-29
SUNGLASSES (K964564)Micron Metal & Plastic Manufactory Co.1997-01-29
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES (K964505)I C Optics, Ltd.1997-01-10
PLASTIC SUNGLASSES (K964316)Medical Reports Exchange, Inc.1996-12-17
SUNGLASSES OR MULTIPLE (K964429)Trade Resources , Ltd.1996-12-12
SUNGLASSES(NON-PRESCRIPTION) (K964413)Ever Prime Enterprises , Ltd.1996-11-25
SPENSER SUNGLASSES AND SPORT SUNGLASSES (K964058)Spencer Products Co.1996-11-25
SUNGLASSES (K964082)Neo Vu, Inc.1996-11-25
VARIOUS SUNGLASSES (NON-PRESCRIPTION) (K963890)Italian Eyewear, Inc.1996-11-19
DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS (K963955)Bert & Joe'S, Inc.1996-11-19
FLYWAY (K963968)Look Style, S.R.L.1996-11-19
C.O.L.D.A. (K963630)C.O.L.D.A. S.N.C.1996-10-18
ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES (K962279)Jane Fui Optical Co., Ltd.1996-08-26
RAVEN EYE- EYE WEAR (SUNGLASSES) (K963284)Raven Eye, Inc.1996-08-26
RAVEN EYE, INC.- EYE WEAR (K962940)Raven Eye, Inc.1996-08-26
LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES (K963083)Piazza Optical Corp.1996-08-26
SUNQUEST INTERNATIONAL (K963059)Sunquest Intl., Inc.1996-08-23
FITO DIDO (K963075)Framesmart, Inc.1996-08-22
MARCELLA CARAN (K962912)Framesmart, Inc.1996-08-22
EAGLE EYES SUNGLASSES (K962287)Positive Response Television1996-08-14
CENTER OPTICAL GLASSES (K962298)Mirage Eyewear, Inc.1996-07-25
SUNGLASSES (NON-PRESCRIPTION) (K962775)Canadd Trading Co.1996-07-25
SOMA (K962725)Soma International , Ltd.1996-07-25
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. (K962382)Xiamen Chingsong Optical Industrial Co., Ltd.1996-07-25
(BRAND NAME) SUNGLASS FRAMES (K962478)Custom Optical Frames, Inc.1996-07-25
SUNGLASSES, GAUDI SUN LINE (K962636)Gaudi Spa1996-07-25
NIKE V8 AND NIKE V12 (K962412)Nike, Inc.1996-07-03
NON-GENERIC (K962310)Classic Elegance Intl., Inc.1996-07-03
SUNGLASSES (K962436)Chungsin Kau Optical Mfy. Co. , Ltd.1996-07-02
MAGNETO EYEWEAR (K962169)Nike, Inc.1996-06-24
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 (K962107)Leonachi, Inc.1996-06-20
NON-PRESCRIPTION SUNGLASSES (K961990)Rokko Stars Co., Ltd.1996-06-06
SUNGLASSES (K961146)Erica Optical Co.1996-05-31
SUNGLASSES (K960953)Galilee Optics1996-05-31
MISTRAL SUNGLASSES (K960668)Mistral Optical1996-05-31
SUNGLASSES (K960818)Visard Srl1996-05-31
CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY (K961746)Eurotrends Eyewear, Inc.1996-05-16
STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES (K961286)Intl. Optical Mfg. Co., Ltd.1996-05-16
SPECTACLE FRAMES/SUNGLASSES (K954419)Ami Fashion1996-05-16
TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES (K961523)Dorda Toys1996-05-13
SUN CLIP (K961603)Intromark, Inc.1996-05-13
EVERGLORY SUNGLASSES (K960735)Everglory Creations, Inc.1996-05-13
AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE (K943145)The Monticello Group, Inc.1996-04-29
VISARD SUNGLASSES (K961117)Visard Srl1996-04-24
D & K SUNGLASSES (K960798)D&K Stores, Inc.1996-04-24
SUNGLASSES (K961128)Vision-Pro Industrial, Ltd.1996-04-24
OAKLEY, INC SUNGLASSES (K961268)Oakley, Inc.1996-04-24
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