Device product

SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

Z-1385-2024

January 29, 2024

Class II

Product summary

Firm: Olympus Corporation of the Americas
Event: Event 94125
Status: Ongoing
Classification: Class II
Quantity: 203 Units (OUS Only)
Official record key: device-enforcement:Z-1385-2024

Official wording

Reason: A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

Code information: Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.

Distribution pattern: Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.