Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
K-Number: K250168 · 2025-12-30
ApplicantLucas Lifecare
Decision Date2025-12-30
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a medical device manufactured by Lucas Lifecare. It received FDA 510(k) clearance on 2025-12-30 under approval number K250168. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer?
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2025-12-30. It is manufactured by Lucas Lifecare. The 510(k) number is K250168.
When was Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer approved by the FDA?
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer received FDA 510(k) clearance on 2025-12-30, under approval number K250168.
What company makes Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer?
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is manufactured by Lucas Lifecare.
What is the FDA product code for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer?
The FDA product code for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is FLE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.