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FDA 510(k)

OPTOVISION Endoscopic Light Source Unit

K-Number: K243591 · 2025-02-19

ApplicantOptosurgical, LLC
Decision Date2025-02-19
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTOVISION Endoscopic Light Source Unit is the device name listed in this FDA 510(k) record. The listed applicant is Optosurgical, LLC. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K243591. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTOVISION Endoscopic Light Source Unit?

OPTOVISION Endoscopic Light Source Unit is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Optosurgical, LLC. The 510(k) number is K243591.

When did OPTOVISION Endoscopic Light Source Unit receive FDA 510(k) clearance?

OPTOVISION Endoscopic Light Source Unit received FDA 510(k) clearance on 2025-02-19, under 510(k) number K243591.

Who is the listed applicant for OPTOVISION Endoscopic Light Source Unit?

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

What is the FDA product code for OPTOVISION Endoscopic Light Source Unit?

The FDA product code for OPTOVISION Endoscopic Light Source Unit is OWN.

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Related Devices (Code: OWN)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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