Salon Art Company Limited · 89-08 · CHINA
For Salon Art Company Limited · 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 HIFU Ultrasonic Skin Lift (Beauty Machine) | HIFU Ultrasonic Skin Lift (Beauty Machine) | HIFU Ultrasonic Skin Lift (Beauty Machine) | Air Pressure Body Slimming Suit; product code is 79 L - - FL Instrument, Ultrasonic Surgical | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite | 89 I - - SA Massager, Therapeutic, Electric; date published is 04/08/2015; address is 7 D 22 Royalpark Plaza Helong Road First , Guangzhou, CHINA, verified against its source on 2026-09-16.
- Firm
- Salon Art Company Limited 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
- 7 D 22 Royalpark Plaza Helong Road First , Guangzhou, CHINA verified
- Date published
- 04/08/2015 verified
- Product code
- 79 L - - FL Instrument, Ultrasonic Surgical | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- HIFU Ultrasonic Skin Lift (Beauty Machine) | HIFU Ultrasonic Skin Lift (Beauty Machine) | HIFU Ultrasonic Skin Lift (Beauty Machine) | Air Pressure Body Slimming Suit 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 | Class II device each item verified
What the source says
Salon Art Company Limited Date Published : 04/08/2015 7 D 22 Royalpark Plaza Helong Road First , Guangzhou, CHINA 79 L - - FL Instrument, Ultrasonic Surgical Date Published: 10/18/2017 Desc: HIFU Ultrasonic Skin Lift (Beauty Machine) Notes: Class II device without a valid 510K 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 10/18/2017 Desc: HIFU Ultrasonic Skin Lift (Beauty Machine) Notes: Class II device without a valid 510K 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite Date Published: 10/18/2017 Desc: HIFU Ultrasonic Skin Lift (Beauty Machine) Notes: Class II device without a valid 510K 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/08/2015 Desc: Air Pressure Body Slimming Suit Notes: Class II device
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html