# Come Beauty Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Room 129A F/3 , 121 Guangyuanxilu , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 09/09/2013 _(verified: appears in the quote below)_
- **Product code:** 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption _(verified: appears in the quote below)_
- **Product:** Massager/Vibrator _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).