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FDA 510(k)

Leos Laser and Endoscopy System

K-Number: K240615 · 2025-04-03

ApplicantBeaver-Visitec International, Inc.
Decision Date2025-04-03
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Leos Laser and Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Beaver-Visitec International, Inc.. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K240615. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leos Laser and Endoscopy System?

Leos Laser and Endoscopy System is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Beaver-Visitec International, Inc.. The 510(k) number is K240615.

When did Leos Laser and Endoscopy System receive FDA 510(k) clearance?

Leos Laser and Endoscopy System received FDA 510(k) clearance on 2025-04-03, under 510(k) number K240615.

Who is the listed applicant for Leos Laser and Endoscopy System?

The FDA 510(k) record lists Beaver-Visitec International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leos Laser and Endoscopy System?

The FDA product code for Leos Laser and Endoscopy System is HQF.

Related Clinical Trials

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.

NCT03844828Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian EyesACTIVE_NOT_RECRUITING

Other records listing Beaver-Visitec International, 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.

PMA P240038intraocular lens

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K242397LYNX PhotocoagulatorNorlase ApsK233911VISULAS combiCarl Zeiss Meditec, AG

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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