# OPATRA · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For OPATRA · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; product is Synergy Eye Massager | Synergy Face Massager | Synergy Eye Massager | Synergy Face Massager | Synergy Neck Massager Model BP-1808 | Synergy Eye Massager | Synergy Face Massager | Synergy Neck Massager Model BP-1808 | Synergy Eye Massager; product code is 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HS Light Based over the counter wrinkle reduction | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - RO Vibrator, Therapeutic | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 01/22/2020; address is Dalton House , 60 Windsor Avenue , London, MRT UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** OPATRA _(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:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Dalton House , 60 Windsor Avenue , London, MRT UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 01/22/2020 _(verified: appears in the quote below)_
- **Product code:** 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - HS Light Based over the counter wrinkle reduction | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - RO Vibrator, Therapeutic | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Synergy Eye Massager | Synergy Face Massager | Synergy Eye Massager | Synergy Face Massager | Synergy Neck Massager Model BP-1808 | Synergy Eye Massager | Synergy Face Massager | Synergy Neck Massager Model BP-1808 | Synergy Eye Massager _(verified: each item appears in the quote below)_

## What the source says

> OPATRA Date Published : 01/22/2020 Dalton House , 60 Windsor Avenue , London, MRT UNITED KINGDOM 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 01/22/2020 Desc: Synergy Eye Massager 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 01/22/2020 Desc: Synergy Face Massager 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/22/2020 Desc: Synergy Eye Massager 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/22/2020 Desc: Synergy Face Massager 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 10/19/2023 Desc: Synergy Neck Massager Model BP-1808 89 I - - RO Vibrator, Therapeutic Date Published: 01/22/2020 Desc: Synergy Eye Massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/22/2020 Desc: Synergy Face Massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/19/2023 Desc: Synergy Neck Massager Model BP-1808 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/22/2020 Desc: Synergy Eye Massager

## 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/).