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FDA 510(k)

EQUIA LC ONE

K-Number: K250953 · 2025-09-19

ApplicantGC America, Inc.
Decision Date2025-09-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EQUIA LC ONE is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2025-09-19 under approval 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. It is manufactured by GC America, Inc.. The 510(k) number is K250953.

When was EQUIA LC ONE approved by the FDA?

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

What company makes EQUIA LC ONE?

EQUIA LC ONE is manufactured by GC America, Inc..

What is the FDA product code for EQUIA LC ONE?

The FDA product code for EQUIA LC ONE is EMA.

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Related Devices (Code: EMA)

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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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