OPATRA · 89-08 · UNITED KINGDOM

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
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
Address: Dalton House , 60 Windsor Avenue , London, MRT UNITED KINGDOM verified
Date published: 01/22/2020 verified
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 each item verified
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 each item verified

Sourceaccessdata.fda.gov

Verified2026-09-16

Review by2026-11-15

DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

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

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.

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OPATRA · 89-08 · UNITED KINGDOM

What the source says

Source

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