# Cgb Alpheratz · 89-08 · FRANCE — FDA import alert red lists: firms subject to detention without physical examination

For Cgb Alpheratz · 89-08 · FRANCE, 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 FRANCE; product is DualChroma/Chromapuncteur-10 | DualChroma/Chromapuncteur-10; product code is 79 O - - NE Powered light based non-laser surgical instrument | 89 I - - SA Massager, Therapeutic, Electric; date published is 04/27/2018; address is 21 Des Tourrades , Mandelieu, FRANCE, verified against its source on 2026-09-16.

- **Firm:** Cgb Alpheratz _(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:** FRANCE _(verified: appears in the quote below)_
- **Address:** 21 Des Tourrades , Mandelieu, FRANCE _(verified: appears in the quote below)_
- **Date published:** 04/27/2018 _(verified: appears in the quote below)_
- **Product code:** 79 O - - NE Powered light based non-laser surgical instrument | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** DualChroma/Chromapuncteur-10 | DualChroma/Chromapuncteur-10 _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Cgb Alpheratz Date Published : 04/27/2018 21 Des Tourrades , Mandelieu, FRANCE 79 O - - NE Powered light based non-laser surgical instrument Date Published: 04/27/2018 Desc: DualChroma/Chromapuncteur-10 Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/27/2018 Desc: DualChroma/Chromapuncteur-10 Notes: Class II

## 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/).