Acmedi Korea Co. · 89-08 · KOREA (THE REPUBLIC OF)
For Acmedi Korea Co. · 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 Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere); product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 N - - RJ Ultrasound, Skin Permeation | 80 L - - DQ Device, General Medical; date published is 10/23/2018; address is 293 #611, Hyundai 41 Tower , Yangcheon District, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Acmedi Korea Co. 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
- 293 #611, Hyundai 41 Tower , Yangcheon District, Seoul KOREA (THE REPUBLIC OF) verified
- Date published
- 10/23/2018 verified
- Product code
- 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 N - - RJ Ultrasound, Skin Permeation | 80 L - - DQ Device, General Medical each item verified
- Product
- Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | Skin Lifting Device (Plamere) | 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 each item verified
What the source says
Acmedi Korea Co. Date Published : 10/23/2018 293 #611, Hyundai 41 Tower , Yangcheon District, Seoul KOREA (THE REPUBLIC OF) 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 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 80 L - - DQ Device, General Medical Date Published: 10/23/2018 Desc: Skin Lifting Device (Plamere) Notes: Class II device; requires 510(k); or de novo application
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html