OPATRA · 89-08 · UNITED KINGDOM

For OPATRA, import alert is 89-08; country is UNITED KINGDOM; 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 Synergy Face Massager | Synergy Eye Massager | Synergy Face Massager | Synergy Neck Massager Model BP-1808 | Synergy Eye Massager | Synergy Eye Massager | Synergy Face Massager | Synergy Eye Massager | Synergy Neck Massager Model BP-1808; 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 2026-09-30.

What the source says

OPATRA Date Published : 01/22/2020 Dalton House , 60 Windsor Avenue , London, MRT UNITED KINGDOM

— accessdata.fda.gov, retrieved 2026-09-22

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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.