510(k) · Cleared

Recalled · 2008

Reprocessed Laser Probe

K012682510(k) TraditionalCleared Nov 8, 200186-day reviewClass II21 CFR 878.4810Recalls 1

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

Sterilmed, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 8, 2001 as substantially equivalent to K840590 (Hgm, Inc., 1984) after an 86-day review. Its family tree reaches back 1 generation to 1984. It has been recalled once.

Decided: Nov 8, 2001
Review: 86 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K840590 (1984). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK840590 Fleischman-Swartz Endo-Ocular ProbeHgm, Inc. · 1984
This deviceK012682 Reprocessed Laser ProbeSterilmed, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K840590	Fleischman-Swartz Endo-Ocular Probe	Hgm, Inc.	1984	—
0 (this device)	K012682	Reprocessed Laser Probe	Sterilmed, Inc.	2001	—

FIG. 1 — Lineage of K012682, 1984–2001Source: 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
*	K840590	Fleischman-Swartz Endo-Ocular Probe Summary page 1 …s Laser, Ophthalmic Class 11, 21 CFR 886.4390 HQF SterilMed’s reprocessed laser probes are substantially equivalent to HGM Inc.’s Fleischman-Swartz Endo-Ocular Probe (K840590), and to the counterpart devices from the original manufacturers. Laser probes are an accessory used as part of a laser delivery…	Hgm, Inc.	1984	—

Also cleared against K840590: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 8, 2008	Not classified	Z-0562-2009	Packaging process control	SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K840590.

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?

These devices are reprocessed laser probes from various original equipment manufacturers (OEMs). Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment.

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/K012682 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012682: Reprocessed Laser Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012682

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026