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Mentor Advent A/B System

by Mentor Ophthalmics, Inc.

510(k) K960765

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960765 Date8 Aug 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Mentor Advent A/B System is a dual-function ultrasonic ophthalmic imaging device classified under 21 CFR 892.1560. It combines A-scan and B-scan modalities to measure ocular parameters, including axial length, anterior chamber depth, and lens thickness, while also enabling intraocular lens (IOL) power calculations for cataract surgery planning.

This system is supplied as a reusable medical device and is intended for use in clinical ophthalmology settings. It requires FDA 510(k) clearance (K960765) and is regulated under the Radiology Advisory Committee. No sterility or single-use designation is specified in the available data.

Other devices from Mentor Ophthalmics, Inc.

Questions

AI-generated answers, 19 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 types of measurements does the Mentor Advent A/B System perform, and how are they useful in cataract surgery planning?

    The Mentor Advent A/B System combines A-scan and B-scan imaging to measure key ocular parameters like axial length, anterior chamber depth, and lens thickness. These measurements are critical for calculating the appropriate intraocular lens (IOL) power before cataract surgery, ensuring accurate lens placement and optimal visual outcomes for the patient.

  • Is the Mentor Advent A/B System designed for single-use or reusable applications in clinical settings?

    The Mentor Advent A/B System is explicitly described as a reusable medical device, meaning it is intended for repeated use in clinical ophthalmology environments. There is no indication of a single-use designation in the available data.

  • How is the Mentor Advent A/B System regulated, and which advisory committee oversees its submissions?

    The Mentor Advent A/B System requires FDA 510(k) clearance under the classification 21 CFR 892.1560, with the submission reviewed by the Radiology Advisory Committee (RA). The device was granted clearance in 1996 under the traditional 510(k) pathway, with the clearance number K960765.

  • What kind of clinical environment is the Mentor Advent A/B System intended for, and does it require any special handling instructions?

    The device is designed for use in clinical ophthalmology settings, where precise ocular measurements are needed. Since it is reusable, proper cleaning, maintenance, and sterilization protocols must be followed to ensure reliability and patient safety. The data does not specify sterility requirements, so adherence to standard reusable medical device protocols is recommended.