# SZ MAGIC · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SZ MAGIC · 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 Facial Massager Machine; Ulthera System | Facial Massager Machine; Ulthera System | Facial Massager Machine; Ulthera System; product code is 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - SA Massager, Therapeutic, Electric; date published is 11/15/2017; address is Baiyun Zone, Shijing Town , Hongxing Industrial No 7 Road , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** SZ MAGIC _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** Baiyun Zone, Shijing Town , Hongxing Industrial No 7 Road , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 11/15/2017 _(verified: appears in the quote below)_
- **Product code:** 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Facial Massager Machine; Ulthera System | Facial Massager Machine; Ulthera System | Facial Massager Machine; Ulthera System _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without a valid 510K ; | Class II device without a valid 510K ; | Class II device without a valid 510K _(verified: each item appears in the quote below)_

## What the source says

> SZ MAGIC Date Published : 11/15/2017 Baiyun Zone, Shijing Town , Hongxing Industrial No 7 Road , Guangzhou, Guangdong CHINA 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 11/15/2017 Desc: Facial Massager Machine; Ulthera System Notes: Class II device without a valid 510K ; 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 11/15/2017 Desc: Facial Massager Machine; Ulthera System Notes: Class II device without a valid 510K ; 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/15/2017 Desc: Facial Massager Machine; Ulthera System Notes: Class II device without a valid 510K

## 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/).