Reference Source

Quaser SRL · 89-08 · ITALY

For Quaser SRL · 89-08 · ITALY, 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 ITALY; product is JALUPRO YOUNG EYE | JALUPRO SUPER HYDRO | JALUPRO SUPER HYDRO | JALUPRO YOUNG EYE; 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 Via Pian due Torri , Roma, ITALY, verified against its source on 2026-09-16.

Firm
Quaser SRL 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
ITALY verified
Address
Via Pian due Torri , Roma, ITALY 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 SUPER HYDRO | JALUPRO YOUNG EYE each item verified
FDA notes
Class III | Class III | Class III | Class III 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

Quaser SRL Date Published : 07/16/2024 Via Pian due Torri , Roma, ITALY 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 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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