# Salon Art Company Limited · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** 7 D 22 Royalpark Plaza Helong Road First , Guangzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 04/08/2015 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** HIFU Ultrasonic Skin Lift (Beauty Machine) | HIFU Ultrasonic Skin Lift (Beauty Machine) | HIFU Ultrasonic Skin Lift (Beauty Machine) | Air Pressure Body Slimming Suit _(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 | Class II device _(verified: each item appears in the quote below)_

## 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

## 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/).