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Allegro Oculyzer

by Wavelight AG

510(k) K071183

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071183 Date20 Jul 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MXK
Device Class
Class II
Regulation
21 CFR Part 886.1850
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 ALLEGRO OCULYZER is an ophthalmic device used for analysis of the anterior segment of the eye. It is a corneal topographer that utilizes a rotating Scheimpflug camera to capture up to 50 pictures in real-time measurement, providing detailed imaging of the corneal surface.

The device is supplied by Wavelight AG and received FDA 510(k) clearance (K071183) on July 20, 2007, under product code MXK and regulation number 886.1850. It is classified as a Class II medical device for ophthalmic use and is intended for use in clinical settings to support refractive surgery planning and corneal assessment.

Questions

AI-generated answers, 23 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 is the ALLEGRO OCULYZER used for?

    The ALLEGRO OCULYZER is used for analysis of the anterior segment of the eye, specifically as a corneal topographer to capture detailed imaging of the corneal surface using a rotating Scheimpflug camera that takes up to 50 pictures in real-time measurement, supporting refractive surgery planning and corneal assessment in clinical settings.

  • How is the ALLEGRO OCULYZER supplied and by whom?

    The ALLEGRO OCULYZER is supplied by Wavelight AG, the manufacturer, and was received as a finished device under FDA 510(k) clearance K071183 on July 20, 2007, for distribution and use in clinical ophthalmic environments.

  • Is the ALLEGRO OCULYZER a single-use or reusable device?

    The ALLEGRO OCULYZER is a reusable ophthalmic device designed for repeated clinical use; it is not a single-use instrument and requires standard cleaning and maintenance between patient uses as per the manufacturer’s instructions for clinical ophthalmic equipment.

  • What regulatory pathway was used for the ALLEGRO OCULYZER?

    The ALLEGRO OCULYZER received FDA 510(k) clearance (K071183) on July 20, 2007, under product code MXK and regulation number 886.1850, classified as a Class II medical device for ophthalmic use based on a traditional submission demonstrating substantial equivalence to a predicate device.

  • What are the key technical specifications of the ALLEGRO OCULYZER’s imaging capability?

    The ALLEGRO OCULYZER utilizes a rotating Scheimpflug camera to capture up to 50 pictures in real-time measurement, enabling detailed imaging of the corneal surface for anterior segment analysis, which supports clinical decision-making in refractive surgery planning and corneal assessment.