GCS GROUP CO LTD · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- 1008 Ho Sunil Technopark Bldg , 555 Dunchondae-Ro; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 10/23/2018 verified
- 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 each item verified
- 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) each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html