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

For SKINREX 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 Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT | Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT; product code is 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat; date published is 11/25/2013; address is 507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** SKINREX 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:** 507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 11/25/2013 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat _(verified: each item appears in the quote below)_
- **Product:** Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT | Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT _(verified: each item appears in the quote below)_
- **FDA notes:** Class III | Class III _(verified: each item appears in the quote below)_

## What the source says

> SKINREX CO., LTD Date Published : 11/25/2013 507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA (THE REPUBLIC OF) 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/25/2013 Desc: Cavi-Lipo Massager Notes: Class III 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/27/2016 Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 11/25/2013 Desc: Cavi-Lipo Massager Notes: Class III 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 04/27/2016 Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT

## 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/).