Vera Wang
Prescilla Amethyst Tortoise Spectacle
430manufacturers in China registered for this device type
3,537catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (213), Guangdong (90), Jiangsu (43). 50 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Shanghai Lucidarx Optical LLC | Shanghai | Shanghai | Contract manufacturer | 9 |
| Objectt Optik Company Limited | Hong Kong | Hong Kong | Contract manufacturer | 8 |
| Riccino (Xiamen) Optical Inc. | Xiamen | Fujian | Contract manufacturer | 8 |
| Wenzhou Weilan Optical Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 8 |
| Wenzhou Summer International Limited | Wenzhou | Zhejiang | Contract manufacturer | 6 |
| Xiamen Tanuo Optical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 6 |
| Danyang Rimesis Optical Glasses Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 5 |
| Jiangsu Yuchang Optical Glasses Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 5 |
| Wenzhou Kangjing Optics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Wenzhou Mingshida Light Industrial Products Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Wenzhou Zengtai Industry AND Trade Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
Showing 12 of 430. All 430 manufacturers in China registered for Frame, Spectacle
Record
| Listed by | Kenmark Optical Co., Inc., United States |
|---|---|
| FDA product code | HQZ |
| Device type | Frame, Spectacle |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5842 |
| Premarket notification | Exempt |
| Record published | 2021-08-12 |
| Record revised | 2021-08-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LEIRWI53 | In distribution | |
| LASYBU51 | In distribution | |
| BERGBK50 | In distribution | |
| EDELBY52 | In distribution | |
| CHNEBK52 | In distribution | |
| AUDEMI52 | In distribution | |
| V37 TA50 | In distribution | |
| JYCERO50 | In distribution | |
| V065BR49 | In distribution | |
| V098IR51 | In distribution | |
| MANONH51 | In distribution | |
| V364BK49 | In distribution | |
| V572BK52 | In distribution | |
| CEDRNV53 | In distribution | |
| V388TE53 | In distribution | |
| RSNABL54 | In distribution | |
| MRNDRY50 | In distribution | |
| V076RO51 | In distribution | |
| BRYSTO54 | In distribution | |
| VA22HV52 | In distribution | |
| V338NV51 | In distribution | |
| SASHST53 | In distribution | |
| TLLETO53 | In distribution | |
| ANTLRY52 | In distribution | |
| V120BK52 | In distribution | |
| MELRBH51 | In distribution | |
| V008TA50 | In distribution | |
| NEPHHN53 | In distribution | |
| V500EM53 | In distribution | |
| GIGRBH48 | In distribution | |
| LEIRBK53 | In distribution | |
| V131ES52 | In distribution | |
| ACACAY51 | In distribution | |
| V099RO49 | In distribution | |
| EVIAJT54 | In distribution | |
| V316TO53 | In distribution | |
| LANTBK51 | In distribution | |
| V375BU53 | In distribution | |
| V067BR52 | In distribution | |
| JSNESU51 | In distribution | |
| V505PL50 | In distribution | |
| JUBLPL51 | In distribution | |
| AVELPL52 | In distribution | |
| V314BK53 | In distribution | |
| V307UM51 | In distribution | |
| V587CR50 | In distribution | |
| V318LE52 | In distribution | |
| V570RG51 | In distribution | |
| V140BK49 | In distribution | |
| ATTRBR52 | In distribution | |
| ACACAY53 | In distribution | |
| V351BR55 | In distribution | |
| V042BR51 | In distribution | |
| V532PC57 | In distribution | |
| NEDAGN50 | In distribution | |
| TSIABR52 | In distribution | |
| V357AZ51 | In distribution | |
| VA47YG55 | In distribution | |
| V376MG49 | In distribution | |
| PLUSCH53 | In distribution | |
| V573BH53 | In distribution | |
| V516SC54 | In distribution | |
| V088BR49 | In distribution | |
| DERYNV53 | In distribution | |
| VL05BK53 | In distribution | |
| LCIESU48 | In distribution | |
| VA02YG53 | In distribution | |
| V573MT53 | In distribution | |
| V021MO51 | In distribution | |
| V052AY52 | In distribution | |
| DRE BK50 | In distribution | |
| V064BD53 | In distribution | |
| V317BK49 | In distribution | |
| V061BK52 | In distribution | |
| V583NO50 | In distribution | |
| V082BU51 | In distribution | |
| V337TE52 | In distribution | |
| ZASUCR52 | In distribution | |
| VESTBR49 | In distribution | |
| VE10BK52 | In distribution | |
| V341BR53 | In distribution | |
| V347TO53 | In distribution | |
| V083SU50 | In distribution | |
| SPLNGM48 | In distribution | |
| V319TA53 | In distribution | |
| VL03BL52 | In distribution | |
| VE01BK53 | In distribution | |
| ARA GM48 | In distribution | |
| V536NV51 | In distribution | |
| EMMYTO53 | In distribution | |
| V369TO51 | In distribution | |
| ZORYBK50 | In distribution | |
| V079GM53 | In distribution | |
| KORABK52 | In distribution | |
| V560GM53 | In distribution | |
| VA17RY56 | In distribution | |
| ALVAMR52 | In distribution | |
| VA35BK52 | In distribution | |
| V035VI50 | In distribution | |
| ALVIBY50 | In distribution | |
| V350BU51 | In distribution | |
| LASYBU49 | In distribution | |
| JSETCU52 | In distribution | |
| V36 TA50 | In distribution | |
| ATTRBK52 | In distribution | |
| ABRERY50 | In distribution | |
| VA49BK54 | In distribution | |
| ALVABK50 | In distribution | |
| RGSTBK50 | In distribution | |
| V318BK52 | In distribution | |
| V310BK51 | In distribution | |
| ISISDO51 | In distribution | |
| LIN SI00 | In distribution | |
| V39 BK50 | In distribution | |
| V313BR50 | In distribution | |
| GALABK51 | In distribution | |
| VA20LI56 | In distribution | |
| V523CF50 | In distribution | |
| V056BK51 | In distribution | |
| V166CG51 | In distribution | |
| VA13BK54 | In distribution | |
| ALVINT52 | In distribution | |
| BLLEEM51 | In distribution | |
| V583SL50 | In distribution | |
| OSA YG55 | In distribution | |
| TLIICY53 | In distribution | |
| V043BU52 | In distribution | |
| V088BR51 | In distribution | |
| BRILNT53 | In distribution | |
| V053LA52 | In distribution | |
| ILYATE50 | In distribution | |
| DVONNV52 | In distribution | |
| SPHICR50 | In distribution | |
| FIORTO53 | In distribution | |
| V45 BK51 | In distribution | |
| V068VI53 | In distribution | |
| V118OR49 | In distribution | |
| RADEHN55 | In distribution | |
| GRGNSP51 | In distribution | |
| V343BR52 | In distribution | |
| VA10GT54 | In distribution | |
| VA34TE52 | In distribution | |
| V386GM52 | In distribution | |
| V023OR53 | In distribution | |
| V504LI53 | In distribution | |
| V332BK51 | In distribution | |
| V571SR53 | In distribution | |
| V366HN52 | In distribution | |
| EPITBH55 | In distribution | |
| V060BK51 | In distribution | |
| V327BK50 | In distribution | |
| V395TE51 | In distribution | |
| CLSTAY50 | In distribution | |
| LUMITO53 | In distribution | |
| VL01CY51 | In distribution | |
| REENYG52 | In distribution | |
| ABREHN50 | In distribution | |
| VIGNRY51 | In distribution | |
| VA06OR53 | In distribution | |
| V162BU52 | In distribution | |
| VA08HN51 | In distribution | |
| V392NO51 | In distribution | |
| ATERTO50 | In distribution | |
| SPLNPC50 | In distribution | |
| VA08TO53 | In distribution | |
| V566BH50 | In distribution | |
| PADMBK54 | In distribution | |
| MGNFTO54 | In distribution | |
| V064NV51 | In distribution | |
| CLIOBT53 | In distribution | |
| MNNALP54 | In distribution | |
| NOUVBR52 | In distribution | |
| GEM BK50 | In distribution | |
| LAVIBK52 | In distribution | |
| V131TA52 | In distribution | |
| NERTRY53 | In distribution | |
| V065BK51 | In distribution | |
| EVADBK52 | In distribution | |
| V062NV52 | In distribution | |
| V531FA51 | In distribution | |
| V548BL47 | In distribution | |
| V308SN51 | In distribution | |
| ASTEBK53 | In distribution | |
| V082BR53 | In distribution | |
| VA50AY54 | In distribution | |
| MIR2LI49 | In distribution | |
| VL05CY53 | In distribution | |
| V515AY51 | In distribution | |
| V540GA52 | In distribution | |
| V347CC53 | In distribution | |
| STLLSM51 | In distribution | |
| V344BK53 | In distribution | |
| V371YE50 | In distribution | |
| TLIAPC54 | In distribution | |
| V194AZ51 | In distribution | |
| V567RO50 | In distribution | |
| FRCASI52 | In distribution | |
| BERNPC51 | In distribution | |
| SLVAAY50 | In distribution | |
| V108WI50 | In distribution | |
| ANGIKT54 | In distribution | |
| V385BK53 | In distribution | |
| OSA BF55 | In distribution | |
| SPLEBK49 | In distribution | |
| BELLAZ51 | In distribution | |
| STRLPB53 | In distribution | |
| MNNAEB54 | In distribution | |
| V095BK51 | In distribution | |
| V325CR50 | In distribution | |
| V331BK49 | In distribution | |
| V058IR51 | In distribution | |
| V085BR54 | In distribution | |
| V322BD52 | In distribution | |
| MLTABK49 | In distribution | |
| DVTAAY50 | In distribution | |
| V059BK53 | In distribution | |
| V322BD50 | In distribution | |
| V567KH50 | In distribution | |
| V009SL49 | In distribution | |
| ZIXITE51 | In distribution | |
| VCTOBB49 | In distribution | |
| CAMMAN53 | In distribution | |
| LAVIBU52 | In distribution | |
| GILITO52 | In distribution | |
| V394BL53 | In distribution | |
| PADMTE54 | In distribution | |
| V566CT50 | In distribution | |
| SHNDBK53 | In distribution | |
| V521DO51 | In distribution | |
| RADETO55 | In distribution | |
| V346RY53 | In distribution | |
| V391CS51 | In distribution | |
| MANOCS51 | In distribution | |
| V399IN52 | In distribution | |
| V339NH51 | In distribution | |
| VA52BH55 | In distribution | |
| VA19TO54 | In distribution | |
| CMEAGM51 | In distribution | |
| CALSCH50 | In distribution | |
| VA11FA53 | In distribution | |
| ADEENV53 | In distribution | |
| NEBLBH51 | In distribution | |
| NICOPC52 | In distribution | |
| BRDIIR51 | In distribution | |
| V028HN52 | In distribution | |
| EXQUBR51 | In distribution | |
| V372BL51 | In distribution | |
| V113PL50 | In distribution | |
| V389HN54 | In distribution | |
| LEYHRA55 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Etnia Eyewear Culture | Etnia Barcelona, Llc. | 5,685 |
| Bbig | BBig B.V. | 3,664 |
| Masunaga since 1905 | Masunaga Optical MFG. Co., Ltd. | 1,892 |
| Lilly Pulitzer | Kenmark Optical Co., Inc. | 1,718 |
| Kensie | Kenmark Optical Co., Inc. | 1,285 |
| Versant Unbranded | FGX International Inc. | 1,056 |
| Kazuo Kawasaki | Masunaga Optical MFG. Co., Ltd. | 1,043 |
| Superflex Collection | WestGroupe Optical Inc. | 989 |
| Original Penguin | Kenmark Optical Co., Inc. | 983 |
| Bellinger | Bellinger A/S | 882 |
| Jhane Barnes | Kenmark Optical Co., Inc. | 864 |
| Dana Buchman | Kenmark Optical Co., Inc. | 851 |
Showing 12 of 872. All products under Frame, Spectacle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K935918 | 1994-02-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.