Tzong Rong Optical Co., Ltd. · 89-08 · CHINA
For Tzong Rong Optical Co., Ltd. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Pinhole Sunglasses | Pinhole Glasses | Pinhole Sunglasses | Pinhole Glasses; product code is 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) | 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive); date published is 05/22/2012; address is Shihling Town , 107 Country Road, West; Shilingzhen Huadou District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Tzong Rong Optical Co., Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Shihling Town , 107 Country Road, West; Shilingzhen Huadou District , Guangzhou, Guangdong CHINA verified
- Date published
- 05/22/2012 verified
- Product code
- 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) | 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) each item verified
- Product
- Pinhole Sunglasses | Pinhole Glasses | Pinhole Sunglasses | Pinhole Glasses each item verified
- FDA notes
- Class II | Class II | Class II | Class II each item verified
What the source says
Tzong Rong Optical Co., Ltd. Date Published : 05/22/2012 Shihling Town , 107 Country Road, West; Shilingzhen Huadou District , Guangzhou, Guangdong CHINA 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 05/22/2012 Desc: Pinhole Sunglasses Notes: Class II 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 05/22/2012 Desc: Pinhole Glasses Notes: Class II 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) Date Published: 05/22/2012 Desc: Pinhole Sunglasses Notes: Class II 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) Date Published: 05/22/2012 Desc: Pinhole Glasses Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html