Reference Source

WELLCOMET GMBH · 89-08 · GERMANY

For WELLCOMET 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 UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen); product code is 53 - - - -- Cosmetics | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 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 listed twice: Am Mantel 4a , Bruchsal, Baden-Wurttemberg GERMANY and Greschbachstr. 2-4 , Karlsruhe, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-30.

Firm
WELLCOMET 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
Am Mantel 4a , Bruchsal, Baden-Wurttemberg GERMANY verified
Greschbachstr. 2-4 , Karlsruhe, Baden-Wurttemberg GERMANY also listed
Date published
06/07/2023 verified
Product code
53 - - - -- Cosmetics | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 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 each item verified
Product
UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | Facial Treatment Device (ECOderm) | Skinova Ultrasound Device | Facial Treatment Device (ECOderm) | UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) each item verified
FDA notes
Class II device; requires 510(k) | Class II device; requires 510(k); or de novo application | Class II device. | Class II device; requires 510(k); or de novo application | Class II device. | Class II device. | Class II device; requires 510(k); or de novo application | Class II device. | Class II device; requires 510(k) each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

WELLCOMET GMBH Date Published : 06/07/2023 Am Mantel 4a , Bruchsal, Baden-Wurttemberg GERMANY

— accessdata.fda.gov, retrieved 2026-09-22

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 - - - -- Cosmetics Date Published: 04/23/2026 Desc: UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) Notes: Class II device; requires 510(k) 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 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. 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 N - - RJ Ultrasound, Skin Permeation Date Published: 06/25/2024 Desc: Facial Treatment Device (ECOderm) Notes: Class II device. 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: 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. 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)

— all from accessdata.fda.gov, retrieved 2026-09-22

The same source also states

WELLCOMET GMBH Date Published : 06/07/2023 Greschbachstr. 2-4 , Karlsruhe, Baden-Wurttemberg GERMANY

— accessdata.fda.gov, retrieved 2026-09-22

Product code

53 - - - -- Cosmetics Date Published: 04/23/2026 Desc: UltraFusion Skin Care Pen; 10 MHz; (UltraFusion Facial Pen) Notes: Class II device; requires 510(k) 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 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

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