# Aosom E-Commerce Inc · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For Aosom E-Commerce Inc · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; 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 2026-09-16.

- **Firm:** Aosom E-Commerce Inc _(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:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** Room 1-1,1-2,No 22 Dajiaochang Road,Zhaobaoshan Street, Zhenhai , Ningbo, Zhejiang HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 03/25/2016 _(verified: appears in the quote below)_
- **Product code:** 80 F - - LE Sterilizer, Steam _(verified: appears in the quote below)_
- **Product:** Soozier 2in1 Personal Facial & Hair Steamer _(verified: appears in the quote below)_
- **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: appears in the quote below)_

## 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 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.

## 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/).