Beijing Medical Radiology Factory · 89-08 · CHINA
For Beijing Medical Radiology Factory, import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html