Paradigm
21-04 Tortoise - Pattern Spectacle
430manufacturers in China registered for this device type
127catalogue 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 | 2021-08-03 |
| 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 |
|---|---|---|
| 2108SA52 | In distribution | |
| 2023GR53 | In distribution | |
| 2020YG51 | In distribution | |
| 2109PR49 | In distribution | |
| 1920SL51 | In distribution | |
| 2102BZ52 | In distribution | |
| 1912TE53 | In distribution | |
| 1924RO48 | In distribution | |
| 2011SL57 | In distribution | |
| 2004SK51 | In distribution | |
| 2106QZ53 | In distribution | |
| 2107DU51 | In distribution | |
| 2022SK50 | In distribution | |
| 1922TO52 | In distribution | |
| 2102AZ52 | In distribution | |
| 1904YG51 | In distribution | |
| 1911RG49 | In distribution | |
| 2021SK51 | In distribution | |
| 2101YG51 | In distribution | |
| 1913RG52 | In distribution | |
| 1907GM52 | In distribution | |
| 1909NV50 | In distribution | |
| 1923TO49 | In distribution | |
| 2010TO55 | In distribution | |
| 2011TO57 | In distribution | |
| 2108TO52 | In distribution | |
| 2001MI48 | In distribution | |
| 1902NV52 | In distribution | |
| 2008SA50 | In distribution | |
| 2021SA51 | In distribution | |
| 2108SL52 | In distribution | |
| 2109TO49 | In distribution | |
| 2003RG53 | In distribution | |
| 1902YG52 | In distribution | |
| 2001SK48 | In distribution | |
| 2006SK51 | In distribution | |
| 2004SN51 | In distribution | |
| 2005GR48 | In distribution | |
| 1910YG52 | In distribution | |
| 2106SH53 | In distribution | |
| 2107TO51 | In distribution | |
| 2023BK53 | In distribution | |
| 1912BK53 | In distribution | |
| 2101TC51 | In distribution | |
| 2002FO53 | In distribution | |
| 2005SP48 | In distribution | |
| 2004TO51 | In distribution | |
| 1906YG53 | In distribution | |
| 2104FO52 | In distribution | |
| 2022GR50 | In distribution | |
| 2009RO54 | In distribution | |
| 1921SL51 | In distribution | |
| 1909YG50 | In distribution | |
| 2105PV53 | In distribution | |
| 2105AZ53 | In distribution | |
| 1909RG50 | In distribution | |
| 1906RG53 | In distribution | |
| 2007SK51 | In distribution | |
| 1902GM52 | In distribution | |
| 1921DN51 | In distribution | |
| 2009GR54 | In distribution | |
| 2003YG53 | In distribution | |
| 1902BZ52 | In distribution | |
| 1901YG52 | In distribution | |
| 1922AZ52 | In distribution | |
| 2108AZ52 | In distribution | |
| 2008SL50 | In distribution | |
| 2106AZ53 | In distribution | |
| 2107CR51 | In distribution | |
| 1920GR51 | In distribution | |
| 1923DN49 | In distribution | |
| 2104AZ52 | In distribution | |
| 2002BK53 | In distribution | |
| 2008TO50 | In distribution | |
| 2007CR51 | In distribution | |
| 2007RO51 | In distribution | |
| 1923RO49 | In distribution | |
| 2023SK53 | In distribution | |
| 2006SL51 | In distribution | |
| 2101BO51 | In distribution | |
| 2010BK55 | In distribution | |
| 1903BK53 | In distribution | |
| 1905SI53 | In distribution | |
| 2002YG53 | In distribution | |
| 1922SN52 | In distribution | |
| 2102YG52 | In distribution | |
| 1903RG53 | In distribution | |
| 1924BK48 | In distribution | |
| 2020BZ51 | In distribution | |
| 2021CR51 | In distribution | |
| 1913SI52 | In distribution | |
| 2010CR55 | In distribution | |
| 2104TO52 | In distribution | |
| 1922CR52 | In distribution | |
| 2001SN48 | In distribution | |
| 2101AZ51 | In distribution | |
| 2103FO52 | In distribution | |
| 2006RO51 | In distribution | |
| 1905YG53 | In distribution | |
| 2105YC53 | In distribution | |
| 2104MN52 | In distribution | |
| 2109SL49 | In distribution | |
| 2008FO50 | In distribution | |
| 2103YG52 | In distribution | |
| 1901NV52 | In distribution | |
| 1924FO48 | In distribution | |
| 2022UM50 | In distribution | |
| 2006TO51 | In distribution | |
| 1910GM52 | In distribution | |
| 2009TO54 | In distribution | |
| 2107AZ51 | In distribution | |
| 1910NV52 | In distribution | |
| 1921GR51 | In distribution | |
| 1906NV53 | In distribution | |
| 1920RO51 | In distribution | |
| 1912YG53 | In distribution | |
| 1907YG52 | In distribution | |
| 1922DU52 | In distribution | |
| 1922FO52 | In distribution | |
| 1922CN52 | In distribution | |
| 1904NV51 | In distribution | |
| 1913YG52 | In distribution | |
| 1901GM52 | In distribution | |
| 1924SL48 | In distribution | |
| 2004UM51 | In distribution | |
| 1903YG53 | In distribution | |
| 1911YG49 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Etnia Eyewear Culture | Etnia Barcelona, Llc. | 5,685 |
| Bbig | BBig B.V. | 3,664 |
| Vera Wang | Kenmark Optical Co., Inc. | 3,537 |
| 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 |
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.