Rsk Med Technologies Co.,Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Rsk Med Technologies Co.,Ltd., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - UH Skin resurfacing rf applicator | 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 89 I - - SA Massager, Therapeutic, Electric; date published is 02/13/2013; address is No. 405, 1310-8, Yeonsan5dong, Yeonjegu , Busan, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Rsk Med Technologies 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
- No. 405, 1310-8, Yeonsan5dong, Yeonjegu , Busan, KOREA (THE REPUBLIC OF) verified
- Date published
- 02/13/2013 verified
- Product code
- 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - UH Skin resurfacing rf applicator | 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles | X-Cure skin pricking instrument with needles each item verified
- FDA notes
- Class II; 2/13/2013 | Class II; 2/13/2013 | Class II; 2/13/2013 | Class II; 2/13/2013 | Class II; 2/13/2013 | class II; 2/13/2013 each item verified
What the source says
Rsk Med Technologies Co.,Ltd. Date Published : 02/13/2013 No. 405, 1310-8, Yeonsan5dong, Yeonjegu , Busan, KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
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 - - ED Brush, Dermabrasion, Manual Date Published: 05/11/2021 Desc: X-Cure skin pricking instrument with needles Notes: Class II; 2/13/2013 79 G - - FE Brush, Dermabrasion Date Published: 05/11/2021 Desc: X-Cure skin pricking instrument with needles Notes: Class II; 2/13/2013 79 O - - UH Skin resurfacing rf applicator Date Published: 05/11/2021 Desc: X-Cure skin pricking instrument with needles Notes: Class II; 2/13/2013 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief Date Published: 05/11/2021 Desc: X-Cure skin pricking instrument with needles Notes: Class II; 2/13/2013 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes Date Published: 05/11/2021 Desc: X-Cure skin pricking instrument with needles Notes: Class II; 2/13/2013 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/11/2021 Desc: X-Cure skin pricking instrument with needles Notes: class II; 2/13/2013
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html