# Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd. · 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 Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | MC 600 Multi Function Anti Pressure Slimming Machine; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 L - - YG Massager, Therapeutic, Manual; date published is 04/05/2013; address is Hutougang, Dachong Industrial Zone , Lishui Town, Nanhai Dist., , Foshan, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd. _(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:** Hutougang, Dachong Industrial Zone , Lishui Town, Nanhai Dist., , Foshan, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/05/2013 _(verified: appears in the quote below)_
- **Product code:** 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 L - - YG Massager, Therapeutic, Manual _(verified: each item appears in the quote below)_
- **Product:** Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | MC 600 Multi Function Anti Pressure Slimming Machine _(verified: each item appears in the quote below)_
- **FDA notes:** Class II, DWPE Date 4/5/2013 | Class II, DWPE Date 4/5/2013 | Class II, DWPE Date 4/5/2013 | Class II, DWPE Date 4/5/2013 | Device Classification Unknown. Some of the indications may be Class I exempt; some may fall under Class II requiring 510(k) notification; some may not have a predicate and may require de novo or PMA. Submission of a 513(g) is recommended so the closest classification can be determined. ; 5/24/2016 _(verified: each item appears in the quote below)_

## What the source says

> Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd. Date Published : 04/05/2013 Hutougang, Dachong Industrial Zone , Lishui Town, Nanhai Dist., , Foshan, Guangdong CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 04/05/2013 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 79 G - - FE Brush, Dermabrasion Date Published: 04/05/2013 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 01/23/2019 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 89 L - - YG Massager, Therapeutic, Manual Date Published: 01/23/2019 Desc: MC 600 Multi Function Anti Pressure Slimming Machine Notes: Device Classification Unknown. Some of the indications may be Class I exempt; some may fall under Class II requiring 510(k) notification; some may not have a predicate and may require de novo or PMA. Submission of a 513(g) is recommended so the closest classification can be determined. ; 5/24/2016

## 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/).