510(k) Report

510(k) · Cleared

Cleared

Q-Switched ND:Yag Ophtalmic Laser (with Slit Lamp), Model Optimis II

K043613510(k) TraditionalCleared Mar 24, 200584-day reviewClass II21 CFR 886.4390

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

Quantel Medical · HQF Laser, Ophthalmic

Cleared on Mar 24, 2005 after an 84-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided
Mar 24, 2005
Review
84 days
Class
Class II
Product code
HQF
Recalls
None
Predicates
1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K043613Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Top candidate predicates for a new HQF device

  1. #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK992824FDA’s K992824 is Laserex ND:Yag Ophthalmic Laser (LQ2106), Alcon ND:Yag Ophthalmic Laser…
Our reading of the summary gave K992824, FDA’s number for Laserex ND:Yag Ophthalmic Laser (LQ2106), Alcon ND:Yag… (Ellex Medical Pty, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “AURAT (Coherent)”. Kept off the family tree.
Summary page 1
…nel: 86 Predicate devices: AURAT ' (Coherent), LQP4106 ERA (Laserex), 3000 LE (Alcon), LQ2106 (Laserex), LQP3106 (Laserex) and 3000LX (Laserex) - see K992824. Device description: The Quantel Optimis II Q-SwitchedNd:YAG Photodisruptor in a Nd:YAG laser which operates…
Ellex Medical Pty, Ltd.1999—

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.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQF

3in 2025

2007: 42008: 32009: 72010: 22011: 42012: 52013: 62014: 32015: 42016: 32017: 32018: 12019: 42020: 42021: 12022: 72023: 52024: 32025: 32026 (partial year): 2
2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007: 198 days median2008: 28 days median2009: 115 days median2011: 128 days median2012: 179 days median2013: 225 days median2014: 215 days median2015: 295 days median2016: 271 days median2017: 189 days median2019: 107 days median2020: 53 days median2022: 86 days median2023: 155 days median2024: 167 days median2025: 264 days median
2007high 295 (2015) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQF

1in 2025

2007: 22008: 12009: 22010: 32011: 52012: 12013: 22014: 42025: 1
2007high 5 (2011) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQF

106in 2025

2007: 602008: 342009: 332010: 432011: 262012: 412013: 392014: 582015: 802016: 1082017: 772018: 822019: 662020: 722021: 1002022: 1112023: 922024: 752025: 106
2007high 111 (2022) · low 26 (2011)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074198260
2008328134
20097115233
20102—343
20114128526
20125179141
20136225239
20143215458
20154295080
201632710108
20173189077
20181—082
20194107066
2020453072
20211—0100
20227860111
20235155092
20243167075
202532641106
20262—0—

What is it indicated for?

The 'Optimis II Q-Switched Nd:YAG Photodisruptor is intended for posterior capsulotomy.

Indications for use as stated in the FDA summary.

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30 FDA decisions under this applicant name. See the company

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Recent decisions in HQF

The HQF category page

  • K252979Voyager DSLT (430840610)Belkin Vision, Ltd. · 2026
  • K251507Integre LioQuantel Medical · 2026
  • K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
  • K243014EyeQ nanoECPEyeq, Inc. · 2025
  • K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 20251 recall

https://510kreport.com/device/K043613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043613: Q-Switched ND:Yag Ophtalmic Laser (with Slit Lamp), Model Optimis II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043613

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026