GCS GROUP CO LTD · 89-08 · KOREA (THE REPUBLIC OF)
For GCS GROUP CO LTD, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; product is Leaf Fusion Plasma | Skin Lifting Device (Plamere) | Leaf Fusion Plasma | Skin Lifting Device (Plamere) | Plaxpot (Model GPX-2000) | Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | Leaf Fusion Plasma; 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 2026-09-30.
- 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 | Skin Lifting Device (Plamere) | Plaxpot (Model GPX-2000) | Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | Leaf Fusion Plasma 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)
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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: 10/23/2018 Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 09/23/2022 Desc: Plaxpot (Model GPX-2000) 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: 02/24/2022 Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application. DWPE Date: 10/23/2018 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/14/2022 Desc: Leaf Fusion Plasma
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html