Zhong Shan Syou Ei Beauty Instrument Co., Ltd. · 89-08 · CHINA
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
- 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
- Longjing Fang Industrial Estate , Chang Ming Shui, Wu Gui Shan , Zhong Shan, Guang Dong CHINA verified
- Date published
- 08/26/2010 verified
- 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. each item verified
- Product
- OXYGEN FACIAL PURIFIER | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) each item verified
- FDA notes
- Problem(s); Lacks 510(k) | Class III | Class III each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html