HQZ
198 FDA 510(k) clearances · Product code
61 daysmedian time to decision
162 days90th percentile
198clearances measured
FDA profile
- Official device name
- Frame, Spectacle
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5842
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1999: 1 · 2000: 3 · 2002: 2 · 2003: 1 · 2006: 2 · 2007: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW (K952597) | Point of View Optical Outlet, Inc. | 1995-09-12 |
| SPECTACLE FRAME (K944313) | Sun Hing Optical Manufactory , Ltd. | 1995-03-28 |
| SPECTACLE FRAME (K945392) | Seo Han Corp., Ltd. | 1994-12-15 |
| SPECTACLE FRAME OR EYEGLASS FRAMES (K945176) | Optipia Trading Co. | 1994-12-15 |
| OPTICAL FRAMES (K945770) | Ramada Optics, Inc. | 1994-12-15 |
| FRAME, SPECTACLES (K945350) | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| MAG-1 SPECTACLE FRAME (K945342) | Criss Optical Mfg. Co., Inc. | 1994-11-28 |
| ARISTAR EYEWEAR, ESPRIT EYEWEAR (K945123) | Aristar Inc. U.S.A. | 1994-11-22 |
| SPECTACLE FRAMES OR EYEGLASS FRAMES (K945340) | Mi Mun Corp. | 1994-11-22 |
| SPECTACLE FRAME (K945323) | M.Y. Vision Corp. | 1994-11-22 |
| FRAME, SPECTACLE (K945450) | Kookje Apis Industrial Co. | 1994-11-22 |
| NIL (K944641) | Max-Vision (H.K.)Limited | 1994-11-14 |
| SPECTACLE FRAMES (K944373) | Custom Optical Frames, Inc. | 1994-09-28 |
| SILHOUETTE, SUNLIMETED,ADIDAS (K944160) | Silhouette Optical , Ltd. | 1994-09-28 |
| SPECTACLE FRAME (K943561) | Australian Optical Co., Inc. | 1994-09-14 |
| SPECTACLE FRAME (K943641) | Australian Optical Co., Inc. | 1994-09-14 |
| SPECTACLE FRAMES (K943792) | Kt Optique, Inc. | 1994-09-14 |
| MAX FRAME DESIGN (K943913) | Noble Optic | 1994-09-07 |
| SPECTACLE FRAMES (K943423) | Galilee Optics | 1994-09-06 |
| FRAME SPECTACLE (K943753) | Optic Tech Corp. | 1994-09-02 |
| FACONNABLE EYEWEAR (K943567) | Blink Designs, Inc. | 1994-08-10 |
| SPECTACLE FRAMES (K943326) | Buffard-La-Doye | 1994-08-10 |
| OPTHALMIC WIPE (K942897) | Surgin Surgical Instrumentation, Inc. | 1994-08-05 |
| VISARD FRAMES (K942478) | Iris Optical, Inc. | 1994-08-05 |
| WINK EYEWEAR (K943507) | Wink Optical, Inc. | 1994-08-05 |
| N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO (K943265) | The First Optical Manufactory , Ltd. | 1994-08-05 |
| SPECTACLE FRAMES (K943198) | Lunettes Folomi S.A. | 1994-08-05 |
| SPECTACLE FRAME (K943085) | Winntics Optical Industry Co. , Ltd. | 1994-08-04 |
| PERSOL, MOSCLHINO, AND GERALD GENTA (K942845) | Persol America, Inc. | 1994-08-04 |
| SPECTACLE FRAME (K943082) | Daewon Optical Co. | 1994-08-04 |
| OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX (K943236) | Optiline Imports and Trade, Inc. | 1994-08-02 |
| SPECTACLE FRAMES (K943442) | Sunny Union Industrial Co., Ltd. | 1994-08-02 |
| SPECTACLE FRAME (K943083) | Pimex Co., Ltd. | 1994-08-02 |
| SPECTACLE FRAME (K943086) | Radiant Spectacles Manufacturers | 1994-08-02 |
| SPECTACLE FRAME (K943084) | Samil Enterprise Co. | 1994-07-25 |
| SPECTACLE FRAMES (K942750) | Aspex Eyewear, Inc. | 1994-07-25 |
| SEIKO EYEGLASS FRAME (K942513) | Seiko Optical Products of America, Inc. | 1994-07-15 |
| EYECOTECH CORP (K941414) | Eyecotech Corp. | 1994-07-12 |
| PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC. (K942348) | Oliver Peoples, Inc. | 1994-07-12 |
| FRAME, SPECTACLE (K942463) | Erica Optical Co. | 1994-07-12 |
| SPECTACLE FRAMES (V.I.P. INT'L) (K940733) | Continental Optical Imports | 1994-06-17 |
| SPECTACLE FRAMES (K941211) | H & M Optical (U.S.A.) , Ltd. | 1994-06-17 |
| SPECTACLE FRAMES, READING GLASSES (K941463) | Well Arts Optical Factory , Ltd. | 1994-06-17 |
| FRAMES - VARIOUS BRAND NAMES (K941767) | Lenscraft, Inc. | 1994-06-03 |
| SPECTACLE FRAMES (K941602) | Slim Occhiali | 1994-06-03 |
| SPECTACLE FRAMES (K941523) | Amore Mio, Inc. | 1994-05-17 |
| SPECTACLE FRAMES (K940504) | Tecnol-Tecnica Nacional DE Oculos Ltda | 1994-05-17 |
| SPECTACLE FRAMES (K941307) | Eyemart Express, Inc. | 1994-05-17 |
| SPECTACLE FRAMES (K940977) | Super Optical, Inc. | 1994-04-29 |
| SPECTACLE FRAMES (WING SHING OPTICAL) (K940077) | Continental Optical Imports | 1994-04-12 |
| EYEGLASS SPECTACLE FRAMES VARIOUS COLLECTIONS (K941052) | Atlantic Optical Co., Inc. | 1994-04-12 |
| FRONTIER NOVELTY DAELIM OPTICAL FRAME (K941059) | Frontier Novelty, Inc. | 1994-04-12 |
| MORRISON FRAME, SPECTACLE (K940853) | Morrison Center | 1994-04-12 |
| ARTSUN OPTICAL FRAME (K940782) | Frontier Novelty, Inc. | 1994-04-12 |
| EYEGLASS FRAMES (PLASTIC) (K940411) | Value Line Optical Services, Inc. | 1994-04-11 |
| DAELIM CORP. EYE WEAR MODEL (K932612) | Daelim Corp. | 1994-04-06 |
| SPECTACLE FRAME (K940326) | D'Tochi, Inc. | 1994-04-06 |
| SPECTACLE FRAMES (K940560) | Optical Xpressions, Ltd. | 1994-04-06 |
| E.M.A. (K940614) | European Manufacturers Agency, Inc. | 1994-04-06 |
| SPECTACLE FRAMES (K935845) | New Star Corp. | 1994-04-06 |
| FRAME (K940312) | Lanner Enterprise Co., Ltd. | 1994-03-01 |
| SPECTACLE FRAMES (K934570) | Chaser Optical Corp. | 1994-03-01 |
| EYEGLASS FRAMES (K936217) | Ocean Optical Co., Inc. | 1994-02-22 |
| SPECTACLE FRAMES (K934466) | Airess, Inc. | 1994-02-22 |
| OPTICAL FRAMES (K936004) | Europa Continental, Inc. | 1994-02-22 |
| EYEGLASS FRAME (K940113) | Wan Wing Optical Co. | 1994-02-22 |
| SPECTACLE FRAMES (K935968) | Sae Biang Optical Co. | 1994-02-22 |
| SPECTACLE FRAMES (K940202) | Sam Chung Optical Co., Ltd. | 1994-02-22 |
| PRESTIGE FRAMES (K940201) | Eye Think Eyewear | 1994-02-22 |
| ELITE COLLECTION (K936149) | Omega Group, Inc. | 1994-02-22 |
| OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASS (K930566) | E.B. Brown Opticians | 1994-02-16 |
| OPTICAL FRAMES AND/OR SUNGLASSES (K935729) | Ivo Eyewear, Inc. | 1994-02-16 |
| SPECTACLE FRAMES (K935605) | Sovereign Eyewear, Inc. | 1994-02-16 |
| SPECTACLE FRAME (K935918) | Kenmark Optical Co., Inc. | 1994-02-16 |
| OPTICAL FRAME COLLECTION NO. 2 (K935954) | Frontier Novelty, Inc. | 1994-02-16 |
| MULTIPLE -SPECTACLE FRAMES/SUNGLASSES (K935798) | Tae Kyung Optical Co., Inc. | 1994-02-16 |
| GLASSES MOLASSES (K930174) | Arthur F. Kozakowski, Jr. | 1994-01-25 |
| SPECTACLE FRAMES AND SUNGLASSES (K934187) | Wah Ming Optical Mfy. , Ltd. | 1994-01-25 |
| APEX OPTICAL IND. CO., EYE WEA MODELS (K932821) | Apex Optical Ind. Co. | 1994-01-25 |
| SPECTACLE FRAMES (K935107) | Mr I'S Optical Boutique | 1994-01-25 |
| SPECTACLE FRAME/EYEGLASS FRAME (K935558) | Modern Optical , Ltd. | 1994-01-25 |
| SPECTACLE FRAMES (K932439) | Styl-Rite Optics, Inc. | 1994-01-03 |
| FRAME SPECTACLE (K934858) | Arno Intl., Inc. | 1993-12-08 |
| SPECTACLE FRAME (K930331) | Australian Optical Co., Inc. | 1993-12-08 |
| SPECTACLE FRAME (K934463) | Good Bond Industrial Corp. | 1993-12-08 |
| FINE OPTICS (K934797) | Fine Optics, Inc. | 1993-12-08 |
| SPECTACLE FRAMES (K934301) | Gernot Lindner, Lunor-Vertrieb | 1993-12-08 |
| TRACTION PRODUCTIONS SPECTACLE FRAMES (K934249) | Traction Productions, USA | 1993-11-02 |
| SIGMA-BRILLEN (OR) MULTIPLE (K930956) | Sigma-Brillen | 1993-10-20 |
| EYEGLASSES FRAMES (K933529) | Vistula Assistance & Consulting Bureau | 1993-10-20 |
| ALDO'S OPTICAL FRAME COLLECTION (K933956) | Frontier Novelty, Inc. | 1993-10-18 |
| FRAMES (K933865) | Hillman'S, the Eyecare Co., Inc. | 1993-10-18 |
| OPTO LINE SRL (K933809) | Optoline S.R.L. | 1993-10-18 |
| SPECTACLE FRAMES (K933991) | U.S. Optical | 1993-10-18 |
| FRAME-SPECTACLE (K933765) | Clearvision Optical Co., Inc. | 1993-10-18 |
| SPECTACLE FRAMES (K933891) | Euro Frame Design, Inc. | 1993-10-18 |
| SPECTACLE FRAMES (K934082) | South American Optical, Inc. | 1993-10-18 |
| MULTIPLE (K933453) | Fortuna Optical Factory , Ltd. | 1993-10-13 |
| MULTIPLE (K933452) | Tae Han Optical Ent. | 1993-10-06 |
| SPECTACLE FRAMES (K934033) | H.M.O. Optical, Inc. | 1993-10-04 |
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