# Oyaga Beauty Equipment Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Oyaga Beauty Equipment 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 GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency machine | GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency machine; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat; date published is 08/19/2012; address is No 142 Dongfeng West Rd , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Oyaga Beauty Equipment 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:** No 142 Dongfeng West Rd , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 08/19/2012 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat _(verified: each item appears in the quote below)_
- **Product:** GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency machine | GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency machine _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Oyaga Beauty Equipment Co Ltd Date Published : 08/19/2012 No 142 Dongfeng West Rd , Guangzhou, Guangdong CHINA 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 08/19/2012 Desc: GS8.0 Cavitation Machine Notes: Class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 08/19/2012 Desc: GRF-11 Monopolor Radio Frequency machine Notes: Class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 08/19/2012 Desc: GS8.0 Cavitation Machine Notes: Class II 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 08/19/2012 Desc: GRF-11 Monopolor Radio Frequency machine Notes: Class II

## 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/).