Beijing Cosmelights Technology Co Ltd · 89-08 · CHINA
For Beijing Cosmelights 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html