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BOSS

by Intelon Optics, Inc.

510(k) K223700Ref Not ApplicableModel BOSS

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223700↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223700 Date16 Aug 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number860006306BOSS98 Basic UDI-DI 00860003630631UDI-DIDate14 Mar 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
BOSS, Not Applicable
Primary DI / UDI-DI
00860003630631
Basic UDI-DI
860006306BOSS98
Direct Marketing DI
00860003630631
510(k) Number
FDA Product Code
MXK
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 886.1850
EU market of registration
Austria
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BOSS is a diagnostic device classified under the Anterior Segment Analysis category, designed for ophthalmic applications. It provides detailed imaging and measurement capabilities for assessing corneal and anterior segment structures, aiding in the evaluation of conditions such as keratoconus, corneal dystrophies, and post-surgical assessments.

The BOSS is supplied as a reusable medical device, intended for use in clinical settings such as ophthalmology clinics and hospitals. It is regulated under FDA 510K and MDR compliance, with a Class II designation. The device requires proper sterilization and maintenance as per manufacturer guidelines, and its use is governed by the specified regulatory authorizations.

Other devices from Intelon Optics, Inc.

  • Boss 1

    Class II

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical conditions can the BOSS diagnostic device help evaluate in ophthalmology?

    The BOSS is designed for detailed imaging and measurement of corneal and anterior segment structures, making it useful for assessing conditions like keratoconus, corneal dystrophies, and post-surgical evaluations. Its anterior segment analysis capabilities allow clinicians to monitor structural changes and diagnose abnormalities in these areas.

  • Is the BOSS intended for single-use or reusable clinical settings, and what maintenance is required?

    The BOSS is supplied as a reusable medical device, intended for use in clinical settings such as ophthalmology clinics and hospitals. Since it is reusable, proper sterilization and maintenance are required as per the manufacturer’s guidelines to ensure safety and functionality between uses.

  • How is the regulatory status of the BOSS defined, and what does this mean for clinicians?

    The BOSS holds FDA 510K clearance and MDR compliance, with a Class II designation. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards for clinical use in ophthalmology. Clinicians can rely on its compliance with these regulatory frameworks.

  • What types of facilities or settings is the BOSS intended for, and why?

    The BOSS is specifically designed for clinical settings such as ophthalmology clinics and hospitals. Its advanced imaging and measurement capabilities for corneal and anterior segment analysis require controlled environments where precise diagnostics are performed, ensuring accurate assessments for patient care.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No