510(k) · Cleared
ClearedLithoblast Single Use Holmium Laser Fibers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dawell Medical, LLC · GEX Powered Laser Surgical Instrument
Cleared on Oct 14, 2025 as substantially equivalent to K170366 (Laser Peripherals, LLC, 2017) after a 214-day review. Its family tree reaches back 23 generations to 1995.
- Decided
- Oct 14, 2025
- Review
- 214 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K943450 (1995). 402 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- 2 generations backK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- 1 generation backK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- This deviceK250776 Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC · 2025
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 10 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 9 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 6 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 5 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 4 generations backK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- 3 generations backK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- 2 generations backK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- 1 generation backK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- This deviceK250776 Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −10 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −9 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −6 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −5 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| −4 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| −3 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| −2 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| −1 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017 | — |
| 0 (this device) | K250776 | Lithoblast Single Use Holmium Laser Fibers | Dawell Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 8 | 0 |
| 1992 | 6 | 0 |
| 1993 | 11 | 0 |
| 1994 | 29 | 0 |
| 1995 | 21 | 0 |
| 1996 | 26 | 0 |
| 1997 | 30 | 0 |
| 1998 | 29 | 0 |
| 1999 | 19 | 0 |
| 2000 | 29 | 0 |
| 2001 | 31 | 0 |
| 2002 | 36 | 0 |
| 2003 | 30 | 0 |
| 2004 | 19 | 0 |
| 2005 | 13 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K170366 | Laser Peripherals, LLC Family of Bare Laser FibersSummary page 5…GEX Panel: General Surgery Devices (DHT4A) 3. PREDICATE DEVICE The predicate device is the Laser Peripherals Family of Laser Fibers, K170366, Laser Peripherals LLC. 1… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 10 companies; a new generation was cleared every 9 months on median.
- 18 of the 402 ancestors have a recall of any class.
- 5 other devices also cite its predicate K170366.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 LithoBlast Single-Use Holmium Laser Fiber is indicated for use in surgical specialties in which a compatible Ho:YAG laser system has received regulatory clearance. LithoBlast surgical fiber optic laser delivery devices are intended for use with any open source cleared surgical laser with an SMA 905 connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250776: Lithoblast Single Use Holmium Laser Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250776
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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