Reference Source

Zhong Shan Native Produce · 89-08 · CHINA

For Zhong Shan Native Produce · 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 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 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C; date published is 08/26/2010; address is Bai Shi Huan Huan Cheng , Zhongsha, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
Zhong Shan Native Produce 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
Bai Shi Huan Huan Cheng , Zhongsha, Guangdong CHINA verified
Date published
08/26/2010 verified
Product code
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) | Ozone-generating device (Oxy Derm; Oxy Lift and Derma Wand) each item verified
FDA notes
Class III | Class III each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Zhong Shan Native Produce Date Published : 08/26/2010 Bai Shi Huan Huan Cheng , Zhongsha, Guangdong CHINA 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

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