Beijing Cosmelights Technology Co Ltd · 89-08 · CHINA
For Beijing Cosmelights Technology Co Ltd, 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 Skin Rejuvenation System (Pulsed Nd-Yag Laser) | Skin Rejuvenation System (Pulsed Nd-Yag Laser) | Skin Rejuvenation System (Pulsed Nd-Yag Laser); product code is 79 G - - EX Powered laser surgical instruments | 79 O - - HT Light based over-the-counter hair removal | 79 O - - NE Powered light based non-laser surgical instrument; date published is 12/10/2014; address is Room 2705 1 Xinghualu , Beijingshi, Beijingshi CHINA, verified against its source on 2026-09-30.
- Firm
- Beijing Cosmelights Technology Co Ltd 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
- Room 2705 1 Xinghualu , Beijingshi, Beijingshi CHINA verified
- Date published
- 12/10/2014 verified
- Product code
- 79 G - - EX Powered laser surgical instruments | 79 O - - HT Light based over-the-counter hair removal | 79 O - - NE Powered light based non-laser surgical instrument each item verified
- Product
- Skin Rejuvenation System (Pulsed Nd-Yag Laser) | Skin Rejuvenation System (Pulsed Nd-Yag Laser) | Skin Rejuvenation System (Pulsed Nd-Yag Laser) each item verified
- FDA notes
- class 2 | class 2 | class 2 each item verified
What the source says
Beijing Cosmelights Technology Co Ltd Date Published : 12/10/2014 Room 2705 1 Xinghualu , 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 G - - EX Powered laser surgical instruments Date Published: 12/10/2014 Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser) Notes: class 2 79 O - - HT Light based over-the-counter hair removal Date Published: 12/10/2014 Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser) Notes: class 2 79 O - - NE Powered light based non-laser surgical instrument Date Published: 12/10/2014 Desc: Skin Rejuvenation System (Pulsed Nd-Yag Laser) Notes: class 2
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html