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FDA 510(k)

Limfa Therapy System (Limfa Therapy)

K-Number: K243165 · 2025-05-15

ApplicantEywa Srl
Decision Date2025-05-15
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Limfa Therapy System (Limfa Therapy) is a medical device manufactured by Eywa Srl. It received FDA 510(k) clearance on 2025-05-15 under approval number K243165. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Limfa Therapy System (Limfa Therapy)?

Limfa Therapy System (Limfa Therapy) is a medical device that received FDA 510(k) clearance on 2025-05-15. It is manufactured by Eywa Srl. The 510(k) number is K243165.

When was Limfa Therapy System (Limfa Therapy) approved by the FDA?

Limfa Therapy System (Limfa Therapy) received FDA 510(k) clearance on 2025-05-15, under approval number K243165.

What company makes Limfa Therapy System (Limfa Therapy)?

Limfa Therapy System (Limfa Therapy) is manufactured by Eywa Srl.

What is the FDA product code for Limfa Therapy System (Limfa Therapy)?

The FDA product code for Limfa Therapy System (Limfa Therapy) is NGX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

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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.

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