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ISL QC 2000

by Intelligent Surgical Lasers, Inc.

510(k) K892058

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 NumberK892058 Date15 Jun 1989ClearedStatusActive

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  • Withdrawn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
LXS
Device Class
Class II
Regulation
21 CFR Part 886.4392
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 ISL QC 2000 is a Neodymium:Yag laser device intended for ophthalmic use, specifically for posterior capsulotomy and cutting pupilla. It is classified as a Class II medical device under FDA regulation 886.4392.

The device was cleared via the FDA 510(k) pathway under K892058, with a traditional clearance decision dated June 15, 1989. It is manufactured by Intelligent Surgical Lasers, Inc., and is supplied as a reusable laser system for use in ophthalmic surgical settings.

Other devices from Intelligent Surgical Lasers, Inc.

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 ISL QC 2000 used for?

    The ISL QC 2000 is intended for ophthalmic use, specifically for performing posterior capsulotomy and cutting the pupilla during surgical procedures, as stated in its device description and regulatory classification.

  • Is the ISL QC 2000 a single-use or reusable device?

    The ISL QC 2000 is supplied as a reusable laser system, meaning it is designed for multiple uses in ophthalmic surgical settings after appropriate cleaning and maintenance between procedures.

  • How was the ISL QC 2000 cleared for market release?

    The ISL QC 2000 received FDA clearance through the traditional 510(k) pathway under submission K892058, with a decision of substantial equivalence granted on June 15, 1989, based on its similarity to legally marketed predicate devices.