Metro Korea Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Metro Korea Co Ltd · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Meta Duo Beauty Device | Meta Duo Beauty Device; product code is 79 G - - EY Motor, Surgical Instrument, Ac-Powered | 79 O - - UH Skin resurfacing rf applicator; date published is 07/13/2012; address is 56-10 Nonhyun-Dongkangnam-Guseoul , Seoulseoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Metro Korea 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 56-10 Nonhyun-Dongkangnam-Guseoul , Seoulseoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 07/13/2012 verified
- Product code
- 79 G - - EY Motor, Surgical Instrument, Ac-Powered | 79 O - - UH Skin resurfacing rf applicator each item verified
- Product
- Meta Duo Beauty Device | Meta Duo Beauty Device each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Metro Korea Co Ltd Date Published : 07/13/2012 56-10 Nonhyun-Dongkangnam-Guseoul , Seoulseoul, KOREA (THE REPUBLIC OF) 79 G - - EY Motor, Surgical Instrument, Ac-Powered Date Published: 07/13/2012 Desc: Meta Duo Beauty Device Notes: Class II 79 O - - UH Skin resurfacing rf applicator Date Published: 07/13/2012 Desc: Meta Duo Beauty Device Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.