Acmedi Korea Co. · 89-08 · KOREA (THE REPUBLIC OF)
For Acmedi Korea Co., 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 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 2026-09-30.
- 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)
— accessdata.fda.gov, retrieved 2026-09-15
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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html