510(k) · Cleared
ClearedMerilas 532A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian AG · HQF Laser, Ophthalmic
Cleared on Dec 14, 2007 as substantially equivalent to K013402 (Carl Zeiss, Inc., 2001) after a 73-day review. Its family tree reaches back 2 generations to 1993. 4 later devices descend from it.
- Decided
- Dec 14, 2007
- Review
- 73 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925642 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK925642 Zeiss Diode-Pumped Solid State LaserCarl Zeiss, Inc. · 1993
- 1 generation backK013402 Visulas 532SCarl Zeiss, Inc. · 2001 · Recalled
- This deviceK072823 Merilas 532AMeridian AG · 2007
- Descendant · cites it directly · 3 of its ownK091064 Navilas Laser SystemOd-Os GmbH · 2009
- Descendant · 2 generations on · 2 of its ownK141851 Navilas Laser SystemOd-Os GmbH · 2015
- Descendant · 3 generations on · 1 of its ownK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
- Descendant · 4 generations on · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
Most influential descendants
Showing 4 of 4 · See all- K091064Navilas Laser SystemOd-Os GmbH · 2009 · cites it directly3descendants
- K141851Navilas Laser SystemOd-Os GmbH · 2015 · 2 generations on2descendants
- K162191NAVILAS Laser SystemOd-Os GmbH · 2016 · 3 generations on1descendant
- K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925642 | Zeiss Diode-Pumped Solid State Laser | Carl Zeiss, Inc. | 1993 | — |
| −1 | K013402 | Visulas 532S | Carl Zeiss, Inc. | 2001 | 1 |
| 0 (this device) | K072823 | Merilas 532A | Meridian AG | 2007 | — |
| +1 | K091064 | Navilas Laser System | Od-Os GmbH | 2009 | — |
| +2 | K141851 | Navilas Laser System | Od-Os GmbH | 2015 | — |
| +3 | K162191 | NAVILAS Laser System | Od-Os GmbH | 2016 | — |
| +4 | K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
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 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K013402 | Visulas 532SSummary page 2…S 532a is substantially equivalent to the following legally marketed device, which has been granted marketing clearance by FDA: Carl Zeiss VISULAS 532s (510(k) # K013402) A side-by-side comparison between the Carl Zeiss VISULAS 532s and the MERILAS 532ct is provided below. Side-by-… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091064 | Navilas Laser System | 2009 | 3 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K091064 (Od-Os GmbH, 2009) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K013402.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The MERILAS 532a is indicated for use in retinal photocoagulation, iridotomy and laser trabeculoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072823: Merilas 532A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072823
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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