# WUHAN GUANGDUN TECHNOLOGY CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For WUHAN GUANGDUN TECHNOLOGY 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 Medical Laser | Medical Laser; product code is 79 G - - EX Powered laser surgical instruments | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy; date published is 08/04/2017; address is F 3 , 303 Optical Valley Avenue; 3f, No. 303 Optical Chip Center, Optical Avenue , Wuhan, Hubei CHINA, verified against its source on 2026-09-16.

- **Firm:** WUHAN GUANGDUN TECHNOLOGY 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 3 , 303 Optical Valley Avenue; 3f, No. 303 Optical Chip Center, Optical Avenue , Wuhan, Hubei CHINA _(verified: appears in the quote below)_
- **Date published:** 08/04/2017 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy _(verified: each item appears in the quote below)_
- **Product:** Medical Laser | Medical Laser _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> WUHAN GUANGDUN TECHNOLOGY CO LTD Date Published : 08/04/2017 F 3 , 303 Optical Valley Avenue; 3f, No. 303 Optical Chip Center, Optical Avenue , Wuhan, Hubei CHINA 79 G - - EX Powered laser surgical instruments Date Published: 08/04/2017 Desc: Medical Laser Notes: Class II 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 08/04/2017 Desc: Medical Laser 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/).