Device product
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Z-2504-2024
Product summary
- Event
- Event 94964
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,585 Units
- Official record key
device-enforcement:Z-2504-2024
Official wording
Reason: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Code information: Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Derived failure modes
-
Unknown
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.