FDA 510(k)

Leos Laser and Endoscopy System

Número K: K240615 · 2025-04-03

RequerenteBeaver-Visitec International, Inc.

Data da decisão2025-04-03

Código do produtoHQF

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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