# Silgreen Inc. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Silgreen Inc. · 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 Iontophoresis device for non-CF diagnosis (Skin care appliance) | Iontophoresis device for non-CF diagnosis (Skin care appliance); product code is 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - SA Massager, Therapeutic, Electric; date published is 01/24/2012; address is 396-2, Daebang-Dong, Dongjak-Ku , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Silgreen Inc. _(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:** 396-2, Daebang-Dong, Dongjak-Ku , Seoul, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 01/24/2012 _(verified: appears in the quote below)_
- **Product code:** 89 E - - GJ Device, Iontophoresis, Other Uses | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Iontophoresis device for non-CF diagnosis (Skin care appliance) | Iontophoresis device for non-CF diagnosis (Skin care appliance) _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Silgreen Inc. Date Published : 01/24/2012 396-2, Daebang-Dong, Dongjak-Ku , Seoul, KOREA (THE REPUBLIC OF) 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 01/24/2012 Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance) Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/24/2012 Desc: Iontophoresis device for non-CF diagnosis (Skin care appliance) Notes: Class II

## 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/).