# Tzong Rong Optical Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Shihling Town , 107 Country Road, West; Shilingzhen Huadou District , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 05/22/2012 _(verified: appears in the quote below)_
- **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) _(verified: each item appears in the quote below)_
- **Product:** Pinhole Sunglasses | Pinhole Glasses | Pinhole Sunglasses | Pinhole Glasses _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).