510(k) · Cleared

Cleared

20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25

K021696510(k) TraditionalCleared Aug 20, 200290-day reviewClass II21 CFR 878.4810

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

Ophthalmed, LLC · GEX Powered Laser Surgical Instrument

Cleared on Aug 20, 2002 as substantially equivalent to K010372 (Lightmed Corp., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.

Decided: Aug 20, 2002
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010372 (2001). 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK010372 Lightlas 532 PhotocoagulatorLightmed Corp. · 2001 · Recalled
This deviceK021696 20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Ophthalmed, LLC · 2002
Descendant · cites it directly · 6 of its ownK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
Descendant · cites it directly · 5 of its ownK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
Descendant · cites it directly · 2 of its ownK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
Descendant · 2 generations on · 1 of its ownK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019
Descendant · 3 generations on · 0 of its ownK220263 Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser…Vortex Surgical, Inc. · 2022 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005high 2 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all

K05080720G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005 · cites it directly6descendants
K121187Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012 · cites it directly5descendants
K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015 · cites it directly2descendants
K191846MAXReach Laser ProbeVortex Surgical, Inc. · 2019 · 2 generations on1descendant
K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical…Vortex Surgical, Inc. · 2022 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010372	Lightlas 532 Photocoagulator	Lightmed Corp.	2001	1
0 (this device)	K021696	20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25	Ophthalmed, LLC	2002	—
+1	K050807	20G Sma Laser Fiber, Model LF100	Ophthalmed, LLC	2005	—
+1	K121187	Katalyst Laser Probes, Katalyst Illuminated Laser Probes	Katalyst Surgical, LLC	2012	—
+1	K142830	Ophthalmed Bending Laser Probes	Ophthalmed, LLC	2015	—
+2	K191846	MAXReach Laser Probe	Vortex Surgical, Inc.	2019	—
+3	K220263	Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex…	Vortex Surgical, Inc.	2022	3

Descendants by year cleared

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

FIG. 1 — Lineage of K021696, 2001–2022Source: 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 GEX? 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 GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K010372	Lightlas 532 Photocoagulator Summary page 1 …ame: Ophthalmic laser 10-Substantial Equivalency is claimed against the following device: LightLas 532 Ophthalmic Photocoagulator Laser from Light med Corporation (510k #K010372) Refer to Appendix 1 for details. 11-Description of the Device: This device consists of the following parts already connected t…	Lightmed Corp.	2001	1

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050807	20G Sma Laser Fiber, Model LF100	Ophthalmed, LLC	2005	6
K121187	Katalyst Laser Probes, Katalyst Illuminated Laser Probes	Katalyst Surgical, LLC	2012	5
K142830	Ophthalmed Bending Laser Probes	Ophthalmed, LLC	2015	2
K133358	Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the…	Nidek Co., Ltd.	2014	0

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 a recall.
Of its descendants, K050807 (Ophthalmed, LLC, 2005) has gone furthest, with 6 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

This device is indicated for use to perform laser photocoagulation treatments inside the eye (i.e., panretinal photocoagulation, macular treatments, endophotocoagulation to ciliary processes, laser trabeculoplasty), during surgical interventions (e.g.: trans pars plana vitrectomy). The operating wavelength is 514 to 532 nm.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K021696 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021696: 20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021696

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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