# Invasix Ltd. · 89-08 · ISRAEL — FDA import alert red lists: firms subject to detention without physical examination

For Invasix Ltd. · 89-08 · ISRAEL, 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 ISRAEL; product is Invasix BodyTite (aka Invasix RFAL; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories; date published is 04/19/2013; address is Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL, verified against its source on 2026-09-16.

- **Firm:** Invasix Ltd. _(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:** ISRAEL _(verified: appears in the quote below)_
- **Address:** Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL _(verified: appears in the quote below)_
- **Date published:** 04/19/2013 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories _(verified: appears in the quote below)_
- **Product:** Invasix BodyTite (aka Invasix RFAL _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Invasix Ltd. Date Published : 04/19/2013 Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 04/19/2013 Desc: Invasix BodyTite (aka Invasix RFAL 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/).