# Creata (Shenzhen) Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Creata (Shenzhen) 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 Pimple Remover; product code is 89 I - - LY Lamp, infrared, therapeutic heating; date published is 01/20/2012; address is 5015 Shennan Road 19f Benyuan Bl , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** Creata (Shenzhen) 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:** 5015 Shennan Road 19f Benyuan Bl , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 01/20/2012 _(verified: appears in the quote below)_
- **Product code:** 89 I - - LY Lamp, infrared, therapeutic heating _(verified: appears in the quote below)_
- **Product:** Pimple Remover _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Creata (Shenzhen) Ltd Date Published : 01/20/2012 5015 Shennan Road 19f Benyuan Bl , Shenzhen, CHINA 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 07/13/2012 Desc: Pimple Remover 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/).