# WELLCOMET GMBH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For WELLCOMET 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 Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) | Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm); product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 - - - -- Cosmetics | 79 N - - RJ Ultrasound, Skin Permeation | 79 N - - RJ Ultrasound, Skin Permeation | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption; date published is 06/07/2023; address is Am Mantel 4a , Bruchsal, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-16.

- **Firm:** WELLCOMET GMBH _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Am Mantel 4a , Bruchsal, Baden-Wurttemberg GERMANY _(verified: appears in the quote below)_
- **Date published:** 06/07/2023 _(verified: appears in the quote below)_
- **Product code:** 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 - - - -- Cosmetics | 79 N - - RJ Ultrasound, Skin Permeation | 79 N - - RJ Ultrasound, Skin Permeation | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption _(verified: each item appears in the quote below)_
- **Product:** Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) | Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device. | Class II device; requires 510(k); or de novo application | Class II device; requires 510(k) | Class II device. | Class II device; requires 510(k); or de novo application | Class II device. | Class II device; requires 510(k) | Class II device; requires 510(k); or de novo application | Class II device. _(verified: each item appears in the quote below)_

## What the source says

> WELLCOMET GMBH Date Published : 06/07/2023 Am Mantel 4a , Bruchsal, Baden-Wurttemberg GERMANY 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 06/25/2024 Desc: Facial Treatment Device (ECOderm) Notes: Class II device. 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 06/07/2023 Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application 53 - - - -- Cosmetics Date Published: 04/23/2026 Desc: UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) Notes: Class II device; requires 510(k) 79 N - - RJ Ultrasound, Skin Permeation Date Published: 06/25/2024 Desc: Facial Treatment Device (ECOderm) Notes: Class II device. 79 N - - RJ Ultrasound, Skin Permeation Date Published: 06/07/2023 Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 06/25/2024 Desc: Facial Treatment Device (ECOderm) Notes: Class II device. 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 04/23/2026 Desc: UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) Notes: Class II device; requires 510(k) 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 06/07/2023 Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 06/25/2024 Desc: Facial Treatment Device (ECOderm) Notes: Class II device.

## The same source also states

> WELLCOMET GMBH Date Published : 06/07/2023 Greschbachstr. 2-4 , Karlsruhe, Baden-Wurttemberg GERMANY 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 06/07/2023 Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application 53 - - - -- Cosmetics Date Published: 04/23/2026 Desc: UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) Notes: Class II device; requires 510(k) 79 N - - RJ Ultrasound, Skin Permeation Date Published: 06/07/2023 Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 06/07/2023 Desc: Skinova Ultrasound Device Notes: Class II device; requires 510(k); or de novo application 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 04/23/2026 Desc: UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) Notes: Class II device; requires 510(k)

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).