PROFESSIONAL DERMA · 89-08 · SWITZERLAND
For PROFESSIONAL DERMA, import alert is 89-08; country is SWITZERLAND; 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 JALUPRO YOUNG EYE | JALUPRO SUPER HYDRO | JALUPRO YOUNG EYE | JALUPRO SUPER HYDRO; product code is 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 07/16/2024; address is Riva Antonio Caccia 1/D 6900 , Lugano, Ticino SWITZERLAND, verified against its source on 2026-09-30.
- Firm
- PROFESSIONAL DERMA 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
- SWITZERLAND verified
- Address
- Riva Antonio Caccia 1/D 6900 , Lugano, Ticino SWITZERLAND verified
- Date published
- 07/16/2024 verified
- Product code
- 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use each item verified
- Product
- JALUPRO YOUNG EYE | JALUPRO SUPER HYDRO | JALUPRO YOUNG EYE | JALUPRO SUPER HYDRO each item verified
- FDA notes
- Class III | Class III | Class III | Class III each item verified
What the source says
PROFESSIONAL DERMA Date Published : 07/16/2024 Riva Antonio Caccia 1/D 6900 , Lugano, Ticino SWITZERLAND
— 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 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 07/16/2024 Desc: JALUPRO YOUNG EYE Notes: Class III 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 07/16/2024 Desc: JALUPRO SUPER HYDRO Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 07/16/2024 Desc: JALUPRO YOUNG EYE Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 07/16/2024 Desc: JALUPRO SUPER HYDRO Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html