510(k) K250168

Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer by Lucas Lifecare — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2025
Date Received
January 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type