# Rsk Med Technologies Co.,Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Rsk Med Technologies 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 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 2026-09-16.

- **Firm:** Rsk Med Technologies Co.,Ltd. _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** No. 405, 1310-8, Yeonsan5dong, Yeonjegu , Busan, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 02/13/2013 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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) 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).