FDA.reportPublic FDA data

LUCAS LIFECARE, LLC

Matched from indexed company URL: Lucas Lifecare

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30253084693025308469LUCAS LIFECARE, LLC1N2026-01-012302 Beloit Ave Janesville WI US 53546

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3337321687834687K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerFLE2025-12-30
3337322027465730K241305LifeRay Intraoral Handheld X-ray SystemEHD2024-07-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLE12025-12-30
EHD12024-07-05

PMN#

GUDID#

Lucas Lifecare - Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a fully automatic tabletop steam sterilizer that uses saturated steam under pressure to sterilize heat- and moisture-resistant reusable loads (solid, hollow, porous, or delicate) in wrapped or unwrapped configurations for medical, dental, surgical, healthcare, and laboratory settings. The unit incorporates a vacuum system for dynamic air removal to support steam penetration, temperature uniformity, and post-sterilization drying (drying with door closed). The sterilizer is microcontroller-controlled with installed software and pre-set sterilization programs, providing validated Class B and Class S cycles along with test cycles including Vacuum Test and Bowie-Dick Test.

Lucas Lifecare, LLC

2026-01-28