Come Beauty Co Ltd · 89-08 · CHINA
For Come Beauty 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 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 2026-09-30.
- 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
— 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 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 09/09/2013 Desc: Massager/Vibrator 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