A&A Worldwide Hong Kong Ltd · 89-08 · HONG KONG SAR
For A&A Worldwide Hong Kong Ltd · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; 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 Flat 6, G/F , Topsail Plaza 11; On Sum Street Siu Lek Yuen Shatin , Fotan, Shatin, HONG KONG SAR, verified against its source on 2026-09-16.
- Firm
- A&A Worldwide Hong Kong 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
- HONG KONG SAR verified
- Address
- Flat 6, G/F , Topsail Plaza 11; On Sum Street Siu Lek Yuen Shatin , Fotan, Shatin, HONG KONG SAR 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
A&A Worldwide Hong Kong Ltd Date Published : 08/19/2012 Flat 6, G/F , Topsail Plaza 11; On Sum Street Siu Lek Yuen Shatin , Fotan, Shatin, HONG KONG SAR 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