# Biorem S.R.L. · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For Biorem S.R.L. · 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 code is 79 G - - EX Powered laser surgical instruments | 79 G - - FD Dermatome; date published is 09/16/2009; address is Via Francesco Angrisani 18A , Agropoli, Salerno ITALY, verified against its source on 2026-09-16.

- **Firm:** Biorem S.R.L. _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Francesco Angrisani 18A , Agropoli, Salerno ITALY _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments | 79 G - - FD Dermatome _(verified: each item appears in the quote below)_
- **FDA notes:** SkinMaster MicroDermabrasion Product 1/2/2002 | SkinMaster MicroDermabrasion Product 1/2/2002 _(verified: each item appears in the quote below)_

## What the source says

> Biorem S.R.L. Date Published : 09/16/2009 Via Francesco Angrisani 18A , Agropoli, Salerno ITALY 79 G - - EX Powered laser surgical instruments Date Published: 09/16/2009 Notes: SkinMaster MicroDermabrasion Product 1/2/2002 79 G - - FD Dermatome Date Published: 09/16/2009 Notes: SkinMaster MicroDermabrasion Product 1/2/2002

## 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/).