510(k) · Cleared
ClearedVapormax II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trimedyne, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 21, 2005 as substantially equivalent to K050412 (Trimedyne, Inc., 2005) and 3 other predicates after an 8-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Dec 21, 2005
- Review
- 8 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K936109 (1994). 42 ancestors in all, the oldest K853620 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 5 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 4 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 3 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 2 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 1 generation backK050412 VapormaxTrimedyne, Inc. · 2005
- This deviceK053457 Vapormax IITrimedyne, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK233157 VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −6 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −4 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −3 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −2 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −1 | K050412 | Vapormax | Trimedyne, Inc. | 2005 | — |
| 0 (this device) | K053457 | Vapormax II | Trimedyne, Inc. | 2005 | — |
| +1 | 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 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 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 |
|---|---|---|
| 2024 | 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 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K050412 | VapormaxSummary page 1…Predicate Device The predicate devices for the VAPORMAX II Side Firing Fiber are: * VAPORMAXTM Side Firing Fiber cleared under K050412; and * UROLASEO Right Angle Laser Fiber cleared under K944204, K954597, and K… | 2005 |
| * | K944204 | Lateralase, ModifiedSummary page 1…ng Fiber are: * VAPORMAXTM Side Firing Fiber cleared under K050412; and * UROLASEO Right Angle Laser Fiber cleared under K944204, K954597, and K970422. IV. Device Description The VAPORMAX 1Iis a single use,… | 1994 |
| * | K954597 | Right Angle Laser FibersSummary page 1…are: * VAPORMAXTM Side Firing Fiber cleared under K050412; and * UROLASEO Right Angle Laser Fiber cleared under K944204, K954597, and K970422. IV. Device Description The VAPORMAX 1Iis a single use, disposabl… | 1996 |
| * | K970422 | Right Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND Laser SystemsSummary page 1…M Side Firing Fiber cleared under K050412; and * UROLASEO Right Angle Laser Fiber cleared under K944204, K954597, and K970422. IV. Device Description The VAPORMAX 1Iis a single use, disposable, side firing, fiber optic energy… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | 2024 | 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?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 42 ancestors has a recall of any class.
- Of its descendants, K233157 (Innovaquartz, LLC, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 II is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.
The VAPORMAX II 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/K053457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053457: Vapormax II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053457
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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