510(k) · Cleared
ClearedRight Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND Laser Systems
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 Apr 21, 1997 as substantially equivalent to K954597 (Trimedyne, Inc., 1996) after a 77-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 21, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922497 (1994). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922497 Optilase ND:Yag Models 1000/4000 Surg Laser SystemTrimedyne, Inc. · 1994
- 1 generation backK954597 Right Angle Laser FibersTrimedyne, Inc. · 1996
- This deviceK970422 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922497 | Optilase ND:Yag Models 1000/4000 Surg Laser System | Trimedyne, Inc. | 1994 | — |
| −1 | K954597 | Right Angle Laser Fibers | Trimedyne, Inc. | 1996 | — |
| 0 (this device) | 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 | — |
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 |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K954597 | Right Angle Laser FibersSummary page 1…r Fiber Classification: Nd:YAG Laser System Accessory to Laser-powered Instrument - Not Classified Predicate Device The predicate devices are those cleared under 510(k) K954597. Device Description The Optilase laser systems are continuous wave Nd:YAG energy sources equipped with an aiming beam, adjustab… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053457 | Vapormax II | 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 3 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K053457 (Trimedyne, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K954597.
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 Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH).
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/K970422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970422: Right Angle Laser Fibers;Optilase ND:Yag Laser;Optilase PL100 ND Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970422
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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