Oyaga Beauty Equipment Co Ltd · 89-08 · CHINA
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
- 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
- No 142 Dongfeng West Rd , Guangzhou, Guangdong CHINA verified
- Date published
- 08/19/2012 verified
- 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 each item verified
- Product
- GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency machine | GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency machine each item verified
- FDA notes
- Class II | Class II | Class II | Class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html