Mt.Derm Gmbh · 89-08 · GERMANY
For Mt.Derm Gmbh · 89-08 · GERMANY, 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 GERMANY; product is Microneedling device | Microneedling device | Manual surgical instrument for general use | Surgical instrument motors and accessories/attachments | Amiea Vytal Skin Microneedling Machine (aesthetic use); product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 G - - AR Suture, Nonabsorbable, Synthetic, Polyamide | 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device; date published is 10/02/2015; address is Gustav-Krone-Str. 3 , Berlin, Berlin GERMANY, verified against its source on 2026-09-16.
- Firm
- Mt.Derm Gmbh 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
- GERMANY verified
- Address
- Gustav-Krone-Str. 3 , Berlin, Berlin GERMANY verified
- Date published
- 10/02/2015 verified
- Product code
- 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 G - - AR Suture, Nonabsorbable, Synthetic, Polyamide | 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device each item verified
- Product
- Microneedling device | Microneedling device | Manual surgical instrument for general use | Surgical instrument motors and accessories/attachments | Amiea Vytal Skin Microneedling Machine (aesthetic use) each item verified
- FDA notes
- Class II | Class II | Class I | Class I | Class II 12/14/2025 each item verified
What the source says
Mt.Derm Gmbh Date Published : 10/02/2015 Gustav-Krone-Str. 3 , Berlin, Berlin GERMANY 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/24/2017 Desc: Microneedling device Notes: Class II 79 G - - AR Suture, Nonabsorbable, Synthetic, Polyamide Date Published: 10/02/2015 Desc: Microneedling device Notes: Class II 79 G - - ED Brush, Dermabrasion, Manual Date Published: 12/05/2025 Desc: Manual surgical instrument for general use Notes: Class I 79 G - - FE Brush, Dermabrasion Date Published: 12/05/2025 Desc: Surgical instrument motors and accessories/attachments Notes: Class I 79 Q - - AI Powered microneedle device Date Published: 06/04/2026 Desc: Amiea Vytal Skin Microneedling Machine (aesthetic use) Notes: Class II 12/14/2025
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html