510(k) · Cleared
ClearedRight Angle Laser Fibers
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 Mar 11, 1996 as substantially equivalent to K922497 (Trimedyne, Inc., 1994) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Mar 11, 1996
- Review
- 160 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K922497 (1994). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK922497 Optilase ND:Yag Models 1000/4000 Surg Laser SystemTrimedyne, Inc. · 1994
- This deviceK954597 Right Angle Laser FibersTrimedyne, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK970422 Right Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND…Trimedyne, Inc. · 1997
- 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
- Descendant · cites it directly · 0 of its ownK991847 Thermoflex SystemArgomed, Inc. · 1999
Most influential descendants
Showing 4 of 4 · See all- K970422Right Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND Laser SystemsTrimedyne, Inc. · 1997 · cites it directly2descendants
- K053457Vapormax IITrimedyne, Inc. · 2005 · cites it directly1descendant
- K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024 · 2 generations on0descendants
- K991847Thermoflex SystemArgomed, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922497 | Optilase ND:Yag Models 1000/4000 Surg Laser System | Trimedyne, Inc. | 1994 | — |
| 0 (this device) | K954597 | Right Angle Laser Fibers | Trimedyne, Inc. | 1996 | — |
| +1 | K970422 | Right Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND Laser Systems | Trimedyne, Inc. | 1997 | — |
| +1 | K053457 | Vapormax II | Trimedyne, Inc. | 2005 | — |
| +2 | K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz, LLC | 2024 | — |
| +1 | K991847 | Thermoflex System | Argomed, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K844204 | FDA’s K844204 is Emit QST Ethosuximide Assay Our OCR of the scanned summary read K844204, FDA’s number for Emit QST Ethosuximide Assay (Syva Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Trimedyne Right Angle Laser Fiber”. Kept off the family tree. Summary page 1…Instrument . Predicate Device The predicate devices for the intended use are various configurations of the Trimedyne Right Angle Laser Fiber cleared under 510(k) number K844204 and the Trimedyne Optilase Nd:YAG Laser Systems cleared under 510(k) numbers K922497 and KS32883. TRIMEDYNE. INC: 2801 BARRANCA… | 1984 |
| * | K922497 | Optilase ND:Yag Models 1000/4000 Surg Laser SystemSummary page 1…configurations of the Trimedyne Right Angle Laser Fiber cleared under 510(k) number K844204 and the Trimedyne Optilase Nd:YAG Laser Systems cleared under 510(k) numbers K922497 and KS32883. TRIMEDYNE. INC: 2801 BARRANCA ROAD PO. BOX 57001, IRVINE CA 62619-7001 714 559-5300, FAX T14 5549-1330 BOO 33 5273… | 1994 |
| * | K932883 | Optilase Model 1000-100 ND: Yag Laser System Our OCR of the scanned summary read K532883, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Trimedyne Optilase Nd:YAG Laser System”. | 1994 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K970422 (Trimedyne, Inc., 1997) has gone furthest, with 2 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 Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation, and hemostasis for the treatment of benign prostatic hyperplasia (BPH) and other urological conditions.
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/K954597 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954597: Right Angle Laser Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954597
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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