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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 a medical device manufactured by Beaver-Visitec International, Inc.. It received FDA 510(k) clearance on 2025-04-03 under approval 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. It is manufactured by Beaver-Visitec International, Inc.. The 510(k) number is K240615.

When was Leos Laser and Endoscopy System approved by the FDA?

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

What company makes Leos Laser and Endoscopy System?

Leos Laser and Endoscopy System is manufactured by Beaver-Visitec International, Inc..

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

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

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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