Zhong Shan Syou Ei Beauty Instrument Co., Ltd. · 89-08 · CHINA
For Zhong Shan Syou Ei Beauty Instrument 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 Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) | OXYGEN FACIAL PURIFIER | 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 2026-09-30.
- 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
- Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) | OXYGEN FACIAL PURIFIER | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) each item verified
- FDA notes
- Class III | Problem(s); Lacks 510(k) | 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
— accessdata.fda.gov, retrieved 2026-09-22
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
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 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 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html