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FDA 510(k)

BOSS™

K-Number: K223700 · 2024-08-16

ApplicantIntelon Optics, Inc.
Decision Date2024-08-16
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOSS™ is the device name listed in this FDA 510(k) record. The listed applicant is Intelon Optics, Inc.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K223700. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSS™?

BOSS™ is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Intelon Optics, Inc.. The 510(k) number is K223700.

When did BOSS™ receive FDA 510(k) clearance?

BOSS™ received FDA 510(k) clearance on 2024-08-16, under 510(k) number K223700.

Who is the listed applicant for BOSS™?

The FDA 510(k) record lists Intelon Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSS™?

The FDA product code for BOSS™ is MXK.

Related Devices (Code: MXK)

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.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbHK201724Pentacam AXL WaveOculus Optikgerate GmbH

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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