Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EndyMed PRO MAX

K-Number: K242996 · 2025-06-10

ApplicantEndymed Medical, Ltd.
Decision Date2025-06-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EndyMed PRO MAX is a medical device manufactured by Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2025-06-10 under approval number K242996. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndyMed PRO MAX?

EndyMed PRO MAX is a medical device that received FDA 510(k) clearance on 2025-06-10. It is manufactured by Endymed Medical, Ltd.. The 510(k) number is K242996.

When was EndyMed PRO MAX approved by the FDA?

EndyMed PRO MAX received FDA 510(k) clearance on 2025-06-10, under approval number K242996.

What company makes EndyMed PRO MAX?

EndyMed PRO MAX is manufactured by Endymed Medical, Ltd..

What is the FDA product code for EndyMed PRO MAX?

The FDA product code for EndyMed PRO MAX is GEI.

Other Devices by Endymed Medical, Ltd.

K161199EndyMed Contour Handpiece K161715EndyGel K222369PURE Laser

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑