SZ MAGIC · 89-08 · CHINA
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
- 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
- Baiyun Zone, Shijing Town , Hongxing Industrial No 7 Road , Guangzhou, Guangdong CHINA verified
- Date published
- 11/15/2017 verified
- 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 each item verified
- Product
- Facial Massager Machine; Ulthera System | Facial Massager Machine; Ulthera System | Facial Massager Machine; Ulthera System each item verified
- FDA notes
- Class II device without a valid 510K ; | Class II device without a valid 510K ; | Class II device without a valid 510K each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html