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FDA 510(k)

Navilas Laser System 577sl (156691)

K-Number: K251772 · 2025-10-29

ApplicantOd-Os GmbH
Decision Date2025-10-29
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Navilas Laser System 577sl (156691) is the device name listed in this FDA 510(k) record. The listed applicant is Od-Os GmbH. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K251772. 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 Navilas Laser System 577sl (156691)?

Navilas Laser System 577sl (156691) is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Od-Os GmbH. The 510(k) number is K251772.

When did Navilas Laser System 577sl (156691) receive FDA 510(k) clearance?

Navilas Laser System 577sl (156691) received FDA 510(k) clearance on 2025-10-29, under 510(k) number K251772.

Who is the listed applicant for Navilas Laser System 577sl (156691)?

The FDA 510(k) record lists Od-Os GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navilas Laser System 577sl (156691)?

The FDA product code for Navilas Laser System 577sl (156691) is HQF.

Other records listing Od-Os GmbH 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.

K162191NAVILAS Laser System

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 MedicalK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase ApsK233911VISULAS combiCarl Zeiss Meditec, AG

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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