Accord Media
Country not established
- Devices
- 1
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Accord Media makes
Accord Media manufactures the ULTRA RENEW PLUS, a device designed for skin renewal and rejuvenation procedures.
The ULTRA RENEW PLUS is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Ultra Renew Plus Ref K132833
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Accord Media, initiated on 2017-12-04. By recorded status: 4 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 4
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 4 Dec 2017 Z-0819-2018 Class II Terminated Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
- 4 Dec 2017 Z-0820-2018 Class II Terminated Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
- 4 Dec 2017 Z-0821-2018 Class II Terminated Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
- 4 Dec 2017 Z-0822-2018 Class II Terminated Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Frequently asked questions
How many devices does Accord Media have in the registry?
The registry currently lists 1 device for Accord Media. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accord Media's devices?
Among its 1 most recently registered device, Accord Media has devices listed in FDA 510(k) (1 device).
What risk classes do Accord Media's devices fall under?
Among its 1 most recently registered device, the classes recorded for Accord Media's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Accord Media?
FDA recall records list 4 recalls initiated by Accord Media, the most recent initiated on 4 Dec 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Accord Media in the registry?
The most recently registered devices listed for Accord Media include ULTRA RENEW PLUS.