# Zhong Shan Syou Ei Beauty Instrument Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Zhong Shan Syou Ei Beauty Instrument 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 OXYGEN FACIAL PURIFIER | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand); product code is 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C; date published is 08/26/2010; address is Longjing Fang Industrial Estate , Chang Ming Shui, Wu Gui Shan , Zhong Shan, Guang Dong CHINA, verified against its source on 2026-09-16.

- **Firm:** Zhong Shan Syou Ei Beauty Instrument 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:** Longjing Fang Industrial Estate , Chang Ming Shui, Wu Gui Shan , Zhong Shan, Guang Dong CHINA _(verified: appears in the quote below)_
- **Date published:** 08/26/2010 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. _(verified: each item appears in the quote below)_
- **Product:** OXYGEN FACIAL PURIFIER | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) _(verified: each item appears in the quote below)_
- **FDA notes:** Problem(s); Lacks 510(k) | Class III | Class III _(verified: each item appears in the quote below)_

## What the source says

> Zhong Shan Syou Ei Beauty Instrument Co., Ltd. Date Published : 08/26/2010 Longjing Fang Industrial Estate , Chang Ming Shui, Wu Gui Shan , Zhong Shan, Guang Dong CHINA 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/07/2015 Desc: OXYGEN FACIAL PURIFIER Notes: Problem(s); Lacks 510(k) 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 08/26/2010 Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) Notes: Class III 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 08/26/2010 Desc: Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) Notes: Class III

## 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/).