Tzong Rong Optical Co., Ltd. · 89-08 · CHINA
For Tzong Rong Optical Co., Ltd., import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html