LoFric Elle Pro
K-Number: K260999 · 2026-04-24
ApplicantWellspect AB
Decision Date2026-04-24
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
LoFric Elle Pro is a medical device manufactured by Wellspect AB. It received FDA 510(k) clearance on 2026-04-24 under approval number K260999. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LoFric Elle Pro?
LoFric Elle Pro is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Wellspect AB. The 510(k) number is K260999.
When was LoFric Elle Pro approved by the FDA?
LoFric Elle Pro received FDA 510(k) clearance on 2026-04-24, under approval number K260999.
What company makes LoFric Elle Pro?
LoFric Elle Pro is manufactured by Wellspect AB.
What is the FDA product code for LoFric Elle Pro?
The FDA product code for LoFric Elle Pro is EZD.
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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.