Salon Art Company Limited · 89-08 · CHINA
For Salon Art Company Limited, 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 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 2026-09-30.
- 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
— 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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html