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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 a medical device manufactured by Optosurgical, LLC. It received FDA 510(k) clearance on 2025-02-19 under approval 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. It is manufactured by Optosurgical, LLC. The 510(k) number is K243591.

When was OPTOVISION Endoscopic Light Source Unit approved by the FDA?

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

What company makes OPTOVISION Endoscopic Light Source Unit?

OPTOVISION Endoscopic Light Source Unit is manufactured by Optosurgical, LLC.

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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Official Source

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