Oyaga Beauty Equipment Co Ltd · 89-08 · CHINA
For Oyaga Beauty Equipment 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 GS8.0 Cavitation Machine | GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency 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 2026-09-30.
- 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 | GS8.0 Cavitation Machine | GRF-11 Monopolor Radio Frequency 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
— accessdata.fda.gov, retrieved 2026-09-22
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 - - 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: 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 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html