# Beijing Medical Radiology Factory · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Beijing Medical Radiology Factory · 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 Led Photorejuvenation Device | Led Photorejuvenation Device | Led Photorejuvenation Device; product code is 79 M - - YH System, Non-Coherent Light, Photodynamic Therapy | 95 R - - HG Light, Spectrum, Broad (Non-Medical), General Optical Products, Non-Medical | 95 R - - HL Laser therapy product; date published is 02/22/2013; address is Lang Jia Yuan 6 Jianwaidajie , Beijingshi, Beijingshi CHINA, verified against its source on 2026-09-16.

- **Firm:** Beijing Medical Radiology Factory _(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:** Lang Jia Yuan 6 Jianwaidajie , Beijingshi, Beijingshi CHINA _(verified: appears in the quote below)_
- **Date published:** 02/22/2013 _(verified: appears in the quote below)_
- **Product code:** 79 M - - YH System, Non-Coherent Light, Photodynamic Therapy | 95 R - - HG Light, Spectrum, Broad (Non-Medical), General Optical Products, Non-Medical | 95 R - - HL Laser therapy product _(verified: each item appears in the quote below)_
- **Product:** Led Photorejuvenation Device | Led Photorejuvenation Device | Led Photorejuvenation Device _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Beijing Medical Radiology Factory Date Published : 02/22/2013 Lang Jia Yuan 6 Jianwaidajie , Beijingshi, Beijingshi CHINA 79 M - - YH System, Non-Coherent Light, Photodynamic Therapy Date Published: 02/22/2013 Desc: Led Photorejuvenation Device Notes: Class II 95 R - - HG Light, Spectrum, Broad (Non-Medical), General Optical Products, Non-Medical Date Published: 02/22/2013 Desc: Led Photorejuvenation Device Notes: class II 95 R - - HL Laser therapy product Date Published: 02/22/2013 Desc: Led Photorejuvenation Device 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/).