Elitone for Men
K-Number: K253285 · 2026-01-23
ApplicantElidah, Inc.
Decision Date2026-01-23
Product CodeQAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Elitone for Men is a medical device manufactured by Elidah, Inc.. It received FDA 510(k) clearance on 2026-01-23 under approval number K253285. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elitone for Men?
Elitone for Men is a medical device that received FDA 510(k) clearance on 2026-01-23. It is manufactured by Elidah, Inc.. The 510(k) number is K253285.
When was Elitone for Men approved by the FDA?
Elitone for Men received FDA 510(k) clearance on 2026-01-23, under approval number K253285.
What company makes Elitone for Men?
Elitone for Men is manufactured by Elidah, Inc..
What is the FDA product code for Elitone for Men?
The FDA product code for Elitone for Men is QAJ.
Other Devices by Elidah, Inc.
Related Devices (Code: QAJ)
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.