Teoxane S.A. · 89-08 · SWITZERLAND
For Teoxane S.A., 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 TEOSYAL PureSense Ultra Deep | TEOSYAL PureSense Deep Lines | TEOSYAL PureSense Global Action; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 03/08/2013; address is Rue De Lyon 105 , Geneva, Geneva SWITZERLAND, verified against its source on 2026-09-30.
- Firm
- Teoxane S.A. 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
- Rue De Lyon 105 , Geneva, Geneva SWITZERLAND verified
- Date published
- 03/08/2013 verified
- Product code
- 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use each item verified
- Product
- TEOSYAL PureSense Ultra Deep | TEOSYAL PureSense Deep Lines | TEOSYAL PureSense Global Action each item verified
- FDA notes
- class II; | class II; | class II; each item verified
What the source says
Teoxane S.A. Date Published : 03/08/2013 Rue De Lyon 105 , Geneva, Geneva 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
79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Ultra Deep Notes: class II; 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Deep Lines Notes: class II; 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Global Action Notes: class II;
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html