# Sunny Optoelectronic Tech Co.Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Sunny Optoelectronic Tech 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 Diode Laser Beauty Machine; product code is 79 G - - EX Powered laser surgical instruments; date published is 02/12/2015; address is F 2 , No 1661 Jia Luo Highway; Jiading , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.

- **Firm:** Sunny Optoelectronic Tech 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:** F 2 , No 1661 Jia Luo Highway; Jiading , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 02/12/2015 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments _(verified: appears in the quote below)_
- **Product:** Diode Laser Beauty Machine _(verified: appears in the quote below)_

## What the source says

> Sunny Optoelectronic Tech Co.Ltd Date Published : 02/12/2015 F 2 , No 1661 Jia Luo Highway; Jiading , Shanghai, Shanghai CHINA 79 G - - EX Powered laser surgical instruments Date Published: 02/12/2015 Desc: Diode Laser Beauty Machine

## 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/).