Come Beauty Co Ltd · 89-08 · CHINA
For Come Beauty 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 Massager/Vibrator; product code is 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption; date published is 09/09/2013; address is Room 129A F/3 , 121 Guangyuanxilu , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Come Beauty 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 129A F/3 , 121 Guangyuanxilu , Guangzhou, Guangdong CHINA verified
- Date published
- 09/09/2013 verified
- Product code
- 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption verified
- Product
- Massager/Vibrator verified
- FDA notes
- Class II verified
What the source says
Come Beauty Co Ltd Date Published : 09/09/2013 Room 129A F/3 , 121 Guangyuanxilu , Guangzhou, Guangdong CHINA 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 09/09/2013 Desc: Massager/Vibrator Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.