510(k) · Cleared
ClearedFiberoptic Laser Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiberoptic Fabrications, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 28, 2012 as substantially equivalent to K934008 (Ceram Optec, Inc., 1994) and 6 other predicates after a 104-day review. Its family tree reaches back 20 generations to 1995. 24 later devices descend from it.
- Decided
- Jun 28, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 20 generations to K943450 (1995). 364 ancestors in all, the oldest K771218 (1978). 24 later devices descend from it, 4 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 2 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 1 generation backK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- This deviceK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- Descendant · cites it directly · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- Descendant · 2 generations on · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- Descendant · 3 generations on · 5 of its ownK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
- Descendant · cites it directly · 5 of its ownK140470 Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire…Oberon GmbH Fiber Technologies · 2014
- Descendant · cites it directly · 5 of its ownK131473 (Quanta System) Surgical Laser FibersQuanta System Spa · 2013 · Recalled
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 3 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 2 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 1 generation backK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- This deviceK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · cites it directly23descendants
- K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · 2 generations on13descendants
- K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022 · 3 generations on5descendants
- K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies · 2014 · cites it directly5descendants
- K131473(Quanta System) Surgical Laser FibersQuanta System Spa · 2013 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −3 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −2 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| −1 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| 0 (this device) | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| +1 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| +2 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017 | — |
| +3 | K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | 2022 | — |
| +1 | K140470 | Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial… | Oberon GmbH Fiber Technologies | 2014 | — |
| +1 | K131473 | (Quanta System) Surgical Laser Fibers | Quanta System Spa | 2013 | 1 |
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 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 24 | 0 |
| 1995 | 18 | 0 |
| 1996 | 24 | 0 |
| 1997 | 28 | 0 |
| 1998 | 25 | 0 |
| 1999 | 17 | 0 |
| 2000 | 28 | 0 |
| 2001 | 30 | 0 |
| 2002 | 36 | 0 |
| 2003 | 30 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K934008 | Megabeam Lateral Fire Fiber Optic Delivery SystSummary page 1…optic laser delivery system Classification Name Surgical laser accessory Predicate Devices Ceramptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (1(110080).… | 1994 |
| * | K943445 | Megabeam Fiber Optic Delivery SystemSummary page 1…ser delivery system Classification Name Surgical laser accessory Predicate Devices Ceramptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (1(110080).… | 1994 |
| * | K943444 | Megabeam Lateral FireSummary page 1…very system Classification Name Surgical laser accessory Predicate Devices Ceramptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (1(110080).… | 1994 |
| * | K943526 | Megabeam Lateral Fire Fiber Optic Delivery SystemSummary page 1…tem Classification Name Surgical laser accessory Predicate Devices Ceramptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (1(110080).… | 1994 |
| * | K943527 | Megabeam Lateral FireSummary page 1…ssification Name Surgical laser accessory Predicate Devices Ceramptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (1(110080).… | 1994 |
| * | K941909 | Mega Beam Lateral FireSummary page 1…ion Name Surgical laser accessory Predicate Devices Ceramptec, Inc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (1(110080). 18 ===… | 1994 |
| * | K110080 | Radial-Emitting Shaped Fiber Optic Delivery SystemSummary page 1…nc MegaBeam Fiber Optic Laser Delivery Systems (K934008,K943445,K943444,K943526,K943527,K941909) Biolitec Radial Emitting shaped fiber optic delivery system (1(110080). 18 ~Of… | 2011 |
What descends from it? (24)
See all 244 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and… | 2013 | 23 |
| K140470 | Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission… | 2014 | 5 |
| K131473 | (Quanta System) Surgical Laser Fibers | 2013 | 5 |
| K151855 | SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral… | 2016 | 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 17 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 16 of the 364 ancestors have a recall of any class.
- Of its descendants, K124003 (Med-Fibers, Inc., 2013) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K934008.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of…
Read the full statement (176 words)
The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG,1.44YAG, and Diode Lasers (635-1900nm) with recommended peak and continuous power from 1-200W based upon fiber diameter. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and lOO0um-200W.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120810: Fiberoptic Laser Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120810
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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