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FDA 510(k)

AS Software Version Asera

K-Number: K260205 · 2026-02-19

ApplicantAS Software, LLC
Decision Date2026-02-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AS Software Version Asera is a medical device manufactured by AS Software, LLC. It received FDA 510(k) clearance on 2026-02-19 under approval number K260205. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS Software Version Asera?

AS Software Version Asera is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by AS Software, LLC. The 510(k) number is K260205.

When was AS Software Version Asera approved by the FDA?

AS Software Version Asera received FDA 510(k) clearance on 2026-02-19, under approval number K260205.

What company makes AS Software Version Asera?

AS Software Version Asera is manufactured by AS Software, LLC.

What is the FDA product code for AS Software Version Asera?

The FDA product code for AS Software Version Asera is LLZ.

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Related PubMed Literature

PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

Related Devices (Code: LLZ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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