# Consultative & Commercial Center " INVET" · 89-08 · UKRAINE — FDA import alert red lists: firms subject to detention without physical examination

For Consultative & Commercial Center " INVET" · 89-08 · UKRAINE, 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 UKRAINE; product is Laser Vision Glasses (Pinhole glasses) | Laser Vision Glasses (Pinhole glasses); product code is 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle | 89 I - - PF Stimulator, Muscle, Powered; date published is 09/16/2009; address is Zabolotnoho vul. 35/37 , Odesa, Odeska UKRAINE, verified against its source on 2026-09-16.

- **Firm:** Consultative & Commercial Center " INVET" _(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:** UKRAINE _(verified: appears in the quote below)_
- **Address:** Zabolotnoho vul. 35/37 , Odesa, Odeska UKRAINE _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle | 89 I - - PF Stimulator, Muscle, Powered _(verified: each item appears in the quote below)_
- **Product:** Laser Vision Glasses (Pinhole glasses) | Laser Vision Glasses (Pinhole glasses) _(verified: each item appears in the quote below)_
- **FDA notes:** 02/6/08 | 02/6/08 | ENART a Tens Device 2/6/2008 Claims related to disorders of the Central Nervous System; the Peripheral Nervous Systm; the Respiratory system; ect. as well as dental diseases _(verified: each item appears in the quote below)_

## What the source says

> Consultative & Commercial Center " INVET" Date Published : 09/16/2009 Zabolotnoho vul. 35/37 , Odesa, Odeska UKRAINE 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 05/03/2021 Desc: Laser Vision Glasses (Pinhole glasses) Notes: 02/6/08 86 H - - QZ Frame, Spectacle Date Published: 05/03/2021 Desc: Laser Vision Glasses (Pinhole glasses) Notes: 02/6/08 89 I - - PF Stimulator, Muscle, Powered Date Published: 09/16/2009 Notes: ENART a Tens Device 2/6/2008 Claims related to disorders of the Central Nervous System; the Peripheral Nervous Systm; the Respiratory system; ect. as well as dental diseases

## 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/).