510(k) · Cleared

Cleared

Microrupter V

K023045510(k) TraditionalCleared Sep 26, 200214-day reviewClass II21 CFR 886.4392

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Meridian AG · LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

Cleared on Sep 26, 2002 as substantially equivalent to K001511 (A.R.C. Laser AG, 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000.

Decided: Sep 26, 2002
Review: 14 days
Class: Class II
Product code: LXS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001511 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK001511 O-Las Ophthalmic PhotodisruptorA.R.C. Laser AG · 2000
This deviceK023045 Microrupter VMeridian AG · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001511	O-Las Ophthalmic Photodisruptor	A.R.C. Laser AG	2000	—
0 (this device)	K023045	Microrupter V	Meridian AG	2002	—

FIG. 1 — Lineage of K023045, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LXS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K001511	O-Las Ophthalmic Photodisruptor Summary page 1 …Nd:YAG laser for posterior Capsulotomy Peripheral lridotomy and Pupillary Membranotomy Predicate Device: A.R.C. Q-las 10 (k001511) Description: The MICRORUPTOR V is a Q-switched Nd:YAG laser system designed for use in ophthalmologic procedures. It has…	A.R.C. Laser AG	2000	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All LXS devices

LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXS

FDA has decided no LXS device since 2007.

Median 510(k) review, days · LXS

Too few LXS 510(k)s in any year since 2007 to give a median.

Recalls per year · LXS

No recall names LXS since 2007.

Adverse event reports per year · LXS

2in 2021

2007high 18 (2015) · low 0 (2008)2025

MAUDE reports naming product code LXS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	3
2008	—	0
2009	—	1
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	3
2015	—	18
2016	—	0
2017	—	3
2018	—	6
2019	—	4
2020	—	1
2021	—	2
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

This device will be used in ophthalmic applications, including:

Posterior Capsulotomy

Peripheral lridotomy

Pupillary Membranectomy

This device is intended for use by skilled Physicians and Healthcare Workers and may only be used under the supervision of a Physician.

Federal law restricts this device to sale by or on the order of a licenced practioner

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023045 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023045: Microrupter V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023045

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026