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Microruptor MR-2 Nd:YAG Laser System

by Meridian AG

PMA P840012510(k) K160677

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization 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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK160677 Date19 May 2017ClearedStatusActive
United StatesFDA PMA PMA 1 supplement NumberP840012 Date31 Jan 1986ApprovedStatusActive

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Generic Name
Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
PMA Number
510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent
PMA Supplement
S001

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 Microruptor MR-2 Nd:YAG Laser System is an ophthalmic laser device designed for use in surgical procedures. It utilizes neodymium:YAG technology to perform precise laser applications within the eye, excluding posterior capsulotomy and pupillary cutting procedures.

This system is manufactured by Meridian AG and is subject to regulatory oversight under FDA 510(k) and PMA authorizations. It is classified under the product code GEX and is intended for professional clinical use in ophthalmic settings.

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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 is the primary use of the Microruptor MR-2 Nd:YAG Laser System?

    The system is an ophthalmic laser designed for specific surgical procedures, excluding posterior capsulotomy and pupillary cutting.

  • Who is the manufacturer of this laser system?

    The Microruptor MR-2 Nd:YAG Laser System is manufactured by Meridian AG, based in Thun, Switzerland.

  • Is this device regulated by the FDA?

    Yes, the device is listed with FDA 510(k) and PMA authorizations, indicating it has undergone regulatory review processes.