Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd. · 89-08 · CHINA
For Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd., 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 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 2026-09-30.
- Firm
- Foshan Nanhai Newface Beauty Instrument Technology Co., Ltd. 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
- Hutougang, Dachong Industrial Zone , Lishui Town, Nanhai Dist., , Foshan, Guangdong CHINA verified
- Date published
- 04/05/2013 verified
- 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 each item verified
- Product
- Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | MC 600 Multi Function Anti Pressure Slimming Machine each item verified
- 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 each item verified
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
— 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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html