Mt.Derm Gmbh · 89-08 · GERMANY
For Mt.Derm Gmbh, import alert is 89-08; country is GERMANY; 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 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 2026-09-30.
- 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
— 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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html