FDA 510(k)

Ion-L

K-Number: K261209 · 2026-06-11

Decision Date2026-06-11

Product CodeMRW

DecisionSubstantially Equivalent

Device Summary

Ion-L is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K261209. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion-L?

Ion-L is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is SurGenTec, LLC. The 510(k) number is K261209.

When did Ion-L receive FDA 510(k) clearance?

Ion-L received FDA 510(k) clearance on 2026-06-11, under 510(k) number K261209.

Who is the listed applicant for Ion-L?

The FDA 510(k) record lists SurGenTec, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ion-L?

The FDA product code for Ion-L is MRW.

Other records listing SurGenTec, LLC as applicant

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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.