OPATRA LIMITED · 89-08 · UNITED KINGDOM
For OPATRA LIMITED · 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 Face Massager | Synergy Eye Massager | Synergy Eye Massager | Synergy Eye Massager | Synergy Face 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 - - RO Vibrator, Therapeutic | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 01/22/2020; address is Gatwick Road , 447 High Road , London, Hry UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- OPATRA LIMITED 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
- Gatwick Road , 447 High Road , London, Hry 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 - - RO Vibrator, Therapeutic | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Synergy Eye Massager | Synergy Face Massager | Synergy Face Massager | Synergy Eye Massager | Synergy Eye Massager | Synergy Eye Massager | Synergy Face Massager each item verified
What the source says
OPATRA LIMITED Date Published : 01/22/2020 Gatwick Road , 447 High Road , London, Hry 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 Face Massager 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 01/22/2020 Desc: Synergy Eye Massager 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 Eye Massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/22/2020 Desc: Synergy Face Massager
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html