Beijing Medical Radiology Factory · 89-08 · CHINA
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
- 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
- Lang Jia Yuan 6 Jianwaidajie , Beijingshi, Beijingshi CHINA verified
- Date published
- 02/22/2013 verified
- 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 each item verified
- Product
- Led Photorejuvenation Device | Led Photorejuvenation Device | Led Photorejuvenation Device each item verified
- FDA notes
- Class II | class II | class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html