510(k) · Cleared

Cleared

Vapormax

K050412510(k) TraditionalCleared Mar 14, 200524-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

Trimedyne, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 14, 2005 as substantially equivalent to K915223 (Trimedyne, Inc., 1992) and 4 other predicates after a 24-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.

Decided: Mar 14, 2005
Review: 24 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K936109 (1994). 36 ancestors in all, the oldest K853620 (1986). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
5 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
4 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
3 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
2 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
1 generation backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
This deviceK050412 VapormaxTrimedyne, Inc. · 2005
Descendant · cites it directly · 1 of its ownK053457 Vapormax IITrimedyne, Inc. · 2005
Descendant · 2 generations on · 0 of its ownK233157 VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024

Most influential descendants

Showing 2 of 2 · See all

K053457Vapormax IITrimedyne, Inc. · 2005 · cites it directly1descendant
K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K936109	Sharplan Model 1120 CO2 Surgical Laser	Sharplan Lasers, Inc.	1994	—
−5	K960521	Sharplan Lasers, Inc. Silktouch Flash Scanner	Sharplan Lasers, Inc.	1996	—
−4	K963339	Coherent Ultrapulse CO2 Surgical Lasers	Coherent Medical Group	1997	—
−3	K974789	Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L	Lumenis, Inc.	1998	—
−2	K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…	Lumenis, Inc.	1999	—
−1	K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…	Lumenis	2001	2
0 (this device)	K050412	Vapormax	Trimedyne, Inc.	2005	—
+1	K053457	Vapormax II	Trimedyne, Inc.	2005	—
+2	K233157	VaporMAX LDD; MOJo LDD; MegaJOULE LDD	Innovaquartz, LLC	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1989	1	0
1990	1	0
1991	3	0
1992	3	0
1993	1	0
1994	3	0
1995	4	0
1996	2	0
1997	2	0
1998	3	0
1999	3	0
2000	1	0
2001	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2024	1	0

FIG. 1 — Lineage of K050412, 1994–2024Source: 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? (5)

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
*	K915223	Metal Enclosed Side Firing Fibers Summary page 1 …rument Ill. Predicate Device The predicate devices for the VAPORMAX Side Firing Fiber are: * Trimedyne Side Firing Fibers cleared under 510(k)s K91 5223, K(992230 and K(022655; and * Lumenis DuoToME SIDELITEITm believed to have been cleared under K(01 1703…	Trimedyne, Inc.	1992	—
*	K992230	Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP Summary page 1 …Predicate Device The predicate devices for the VAPORMAX Side Firing Fiber are: * Trimedyne Side Firing Fibers cleared under 510(k)s K91 5223, K(992230 and K(022655; and * Lumenis DuoToME SIDELITEITm believed to have been cleared under K(01 1703…	Trimedyne, Inc.	1999	—
*	K022655	Trimedyne Side Firing Needle with Vent Sheath Summary page 1 …The predicate devices for the VAPORMAX Side Firing Fiber are: * Trimedyne Side Firing Fibers cleared under 510(k)s K91 5223, K(992230 and K(022655; and * Lumenis DuoToME SIDELITEITm believed to have been cleared under K(01 1703 and/or K990947. IV.…	Trimedyne, Inc.	2002	—
*	K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…	Lumenis	2001	2
*	K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND… Summary page 1 …r 510(k)s K91 5223, K(992230 and K(022655; and * Lumenis DuoToME SIDELITEITm believed to have been cleared under K(01 1703 and/or K990947. IV. Device Description The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery…	Lumenis, Inc.	1999	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K053457	Vapormax II	Trimedyne, Inc.	2005	1

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 11 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
1 of the 36 ancestors has a recall of any class.
Of its descendants, K053457 (Trimedyne, Inc., 2005) has gone furthest, with 1 descendant 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?

The VAPoRMAX is intended for surgical use including: incision, excision, vaporization,

ablation, and coagulation of soft tissue.

The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer

laser with a compatible connector for that laser's cleared indications for use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050412 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050412: Vapormax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050412

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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