Invasix Ltd. · 89-08 · ISRAEL
For Invasix Ltd., import alert is 89-08; country is ISRAEL; 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 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 2026-09-30.
- Firm
- Invasix Ltd. 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
- ISRAEL verified
- Address
- Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL verified
- Date published
- 04/19/2013 verified
- Product code
- 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories verified
- Product
- Invasix BodyTite (aka Invasix RFAL verified
- FDA notes
- Class II verified
What the source says
Invasix Ltd. Date Published : 04/19/2013 Tavor Building , Pob 533 , Yokneam, Ha Zafon ISRAEL
— accessdata.fda.gov, retrieved 2026-09-15
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 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 04/19/2013 Desc: Invasix BodyTite (aka Invasix RFAL Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html