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

For GCS GROUP 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 Leaf Fusion Plasma | Skin Lifting Device (Plamere) | Leaf Fusion Plasma | Plaxpot (Model GPX-2000) | Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | Leaf Fusion Plasma | Skin Lifting Device (Plamere); product code is 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 N - - RJ Ultrasound, Skin Permeation | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 10/23/2018; address is 1008 Ho Sunil Technopark Bldg , 555 Dunchondae-Ro; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** GCS GROUP 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:** 1008 Ho Sunil Technopark Bldg , 555 Dunchondae-Ro; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 10/23/2018 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 N - - RJ Ultrasound, Skin Permeation | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Leaf Fusion Plasma | Skin Lifting Device (Plamere) | Leaf Fusion Plasma | Plaxpot (Model GPX-2000) | Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | Leaf Fusion Plasma | Skin Lifting Device (Plamere) _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device; requires 510(k); or de novo application | Class II device; requires 510(k); or de novo application | Class II device; requires 510(k); or de novo application | Class II device; requires 510(k); or de novo application. DWPE Date: 10/23/2018 _(verified: each item appears in the quote below)_

## What the source says

> GCS GROUP CO LTD Date Published : 10/23/2018 1008 Ho Sunil Technopark Bldg , 555 Dunchondae-Ro; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 11/14/2022 Desc: Leaf Fusion Plasma 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 10/23/2018 Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 11/14/2022 Desc: Leaf Fusion Plasma 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 09/23/2022 Desc: Plaxpot (Model GPX-2000) 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 10/23/2018 Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application 79 N - - RJ Ultrasound, Skin Permeation Date Published: 10/23/2018 Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/14/2022 Desc: Leaf Fusion Plasma 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/24/2022 Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application. DWPE Date: 10/23/2018

## 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/).