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FDA 510(k)

Spectra S1 Pro; Spectra S2 Pro

K-Number: K251423 · 2026-02-06

ApplicantUzinmedicare Co., Ltd.
Decision Date2026-02-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Spectra S1 Pro; Spectra S2 Pro is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251423. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectra S1 Pro; Spectra S2 Pro?

Spectra S1 Pro; Spectra S2 Pro is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Uzinmedicare Co., Ltd.. The 510(k) number is K251423.

When did Spectra S1 Pro; Spectra S2 Pro receive FDA 510(k) clearance?

Spectra S1 Pro; Spectra S2 Pro received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251423.

Who is the listed applicant for Spectra S1 Pro; Spectra S2 Pro?

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

What is the FDA product code for Spectra S1 Pro; Spectra S2 Pro?

The FDA product code for Spectra S1 Pro; Spectra S2 Pro is HGX.

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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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