SZ MAGIC · 89-08 · CHINA
For SZ MAGIC, import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html