510(k) · Cleared

Recalled · 2003

Lightlas 532 Photocoagulator

K010372510(k) TraditionalCleared Aug 22, 2001196-day reviewClass II21 CFR 886.4390Recalls 1

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

Cleared on Aug 22, 2001 after a 196-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it. It has been recalled once.

Decided: Aug 22, 2001
Review: 196 days
Class: Class II
Product code: HQF
Recalls: 1
Predicates: 0

9 later devices descend from it, 1 citing it directly.

This deviceK010372 Lightlas 532 PhotocoagulatorLightmed Corp. · 2001
Descendant · cites it directly · 8 of its ownK021696 20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Ophthalmed, LLC · 2002
Descendant · 2 generations on · 6 of its ownK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
Descendant · 2 generations on · 5 of its ownK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
Descendant · 2 generations on · 2 of its ownK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
Descendant · 3 generations on · 1 of its ownK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2002high 2 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 9 · See all

K02169620G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Ophthalmed, LLC · 2002 · cites it directly8descendants
K05080720G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005 · 2 generations on6descendants
K121187Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012 · 2 generations on5descendants
K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015 · 2 generations on2descendants
K191846MAXReach Laser ProbeVortex Surgical, Inc. · 2019 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010372	Lightlas 532 Photocoagulator	Lightmed Corp.	2001	—
+1	K021696	20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25	Ophthalmed, LLC	2002	—
+2	K050807	20G Sma Laser Fiber, Model LF100	Ophthalmed, LLC	2005	—
+2	K121187	Katalyst Laser Probes, Katalyst Illuminated Laser Probes	Katalyst Surgical, LLC	2012	—
+2	K142830	Ophthalmed Bending Laser Probes	Ophthalmed, LLC	2015	—
+3	K191846	MAXReach Laser Probe	Vortex Surgical, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2012	1	0
2014	2	0
2015	1	0
2019	2	0
2022	1	0

FIG. 1 — Lineage of K010372, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021696	20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25	Ophthalmed, LLC	2002	8

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 11, 2003	Not classified	Z-0228-04	Other	Firm needed to include calibration procedures in user guide.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K021696 (Ophthalmed, LLC, 2002) has gone furthest, with 8 descendants of its own.

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

2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007high 295 (2015) · low 28 (2008)2026

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

Recalls per year · HQF

1in 2025

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

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

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	—

https://510kreport.com/device/K010372 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010372: Lightlas 532 Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010372

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026