Aosom E-Commerce Inc · 89-08 · HONG KONG SAR
For Aosom E-Commerce Inc, import alert is 89-08; country is HONG KONG SAR; 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 Soozier 2in1 Personal Facial & Hair Steamer; product code is 80 F - - LE Sterilizer, Steam; date published is 03/25/2016; address is Room 1-1,1-2,No 22 Dajiaochang Road,Zhaobaoshan Street, Zhenhai , Ningbo, Zhejiang HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Aosom E-Commerce Inc 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
- HONG KONG SAR verified
- Address
- Room 1-1,1-2,No 22 Dajiaochang Road,Zhaobaoshan Street, Zhenhai , Ningbo, Zhejiang HONG KONG SAR verified
- Date published
- 03/25/2016 verified
- Product code
- 80 F - - LE Sterilizer, Steam verified
- Product
- Soozier 2in1 Personal Facial & Hair Steamer verified
- FDA notes
- Unknown Device Classification. Product labeling appear to indicate the device both treats and prevents diseases or conditions including dandruff; "treat the scalp", and skin pigmentation disorders. It also indicates to affect the structure and function of the body of man. Specifically the sponsor describes the device to speed nutrient absorption; sterilize and whiten skin; improve blood circulation and metabolism. verified
What the source says
Aosom E-Commerce Inc Date Published : 03/25/2016 Room 1-1,1-2,No 22 Dajiaochang Road,Zhaobaoshan Street, Zhenhai , Ningbo, Zhejiang HONG KONG SAR
— accessdata.fda.gov, retrieved 2026-09-15
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
80 F - - LE Sterilizer, Steam Date Published: 03/25/2016 Desc: Soozier 2in1 Personal Facial & Hair Steamer Notes: Unknown Device Classification. Product labeling appear to indicate the device both treats and prevents diseases or conditions including dandruff; "treat the scalp", and skin pigmentation disorders. It also indicates to affect the structure and function of the body of man. Specifically the sponsor describes the device to speed nutrient absorption; sterilize and whiten skin; improve blood circulation and metabolism.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html