510(k) · Cleared
ClearedStraight Fire Holmium Laser Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · GEX Powered Laser Surgical Instrument
Cleared on Oct 16, 2008 as substantially equivalent to K050108 (Innovaquartz, 2005) and 1 other predicate after a 15-day review. Its family tree reaches back 6 generations to 1994. 6 later devices descend from it.
- Decided
- Oct 16, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K936109 (1994). 31 ancestors in all, the oldest K853620 (1986). 6 later devices descend from it, 2 citing it directly.
- 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 deviceK082928 Straight Fire Holmium Laser FiberBoston Scientific Corp · 2008
- Descendant · cites it directly · 5 of its ownK100078 Modified Straight Fire Laser FiberBoston Scientific Corp · 2010
- Descendant · 2 generations on · 2 of its ownK110685 Flexiva TractipBoston Scientific Corp · 2011
- Descendant · 2 generations on · 1 of its ownK210925 Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber…Boston Scientific · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK251759 Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber…Boston Scientific Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK140503 Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100078Modified Straight Fire Laser FiberBoston Scientific Corp · 2010 · cites it directly5descendants
- K110685Flexiva TractipBoston Scientific Corp · 2011 · 2 generations on2descendants
- K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific · 2021 · 2 generations on1descendant
- K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation · 2025 · 3 generations on0descendants
- K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific · 2014 · 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) | K082928 | Straight Fire Holmium Laser Fiber | Boston Scientific Corp | 2008 | — |
| +1 | K100078 | Modified Straight Fire Laser Fiber | Boston Scientific Corp | 2010 | — |
| +2 | K110685 | Flexiva Tractip | Boston Scientific Corp | 2011 | — |
| +2 | K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID… | Boston Scientific | 2021 | 7 |
| +3 | K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID… | Boston Scientific Corporation | 2025 | — |
| +2 | K140503 | Flexiva SF Side-Firing Single-Use Laser Fiber | Boston Scientific | 2014 | — |
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 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K050108 | Sureflex and Accuflex Laser Lithotripsy FibersSummary page 1…nd plastic surgery and in dermatology 21 CFR 878.4810, Class II Premarket Notification: InnovaQuartz, Inc., K050108 and Trade name: SlimLineEZTM Fiber Device Common/usual nam… | 2005 |
| * | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)… | 2001 |
What descends from it? (6)
2 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?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K100078 (Boston Scientific Corp, 2010) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K050108.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA-905 connector that have been cleared for surgical use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082928: Straight Fire Holmium Laser Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082928
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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