FDA 510(k)

EQUIA LC ONE

K-Number: K250953 · 2025-09-19

Decision Date2025-09-19

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EQUIA LC ONE is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250953. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUIA LC ONE?

EQUIA LC ONE is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is GC America, Inc.. The 510(k) number is K250953.

When did EQUIA LC ONE receive FDA 510(k) clearance?

EQUIA LC ONE received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250953.

Who is the listed applicant for EQUIA LC ONE?

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

What is the FDA product code for EQUIA LC ONE?

The FDA product code for EQUIA LC ONE is EMA.

Other records listing GC America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.