510(k) · Cleared
ClearedMed-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-Fibers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 17, 2013 as substantially equivalent to K972272 (Laser Peripherals, LLC, 1997) and 16 other predicates after a 22-day review. Its family tree reaches back 21 generations to 1995. 23 later devices descend from it.
- Decided
- Jan 17, 2013
- Review
- 22 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 17
Its longest line of descent runs back 21 generations to K943450 (1995). 399 ancestors in all, the oldest K771218 (1978). 23 later devices descend from it, 3 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 2 generations backK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- 1 generation backK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- This deviceK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- Descendant · cites it directly · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- Descendant · 2 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
- Descendant · 2 generations on · 3 of its ownK160513 Quanta System Surgical Laser fibersQuanta System Spa · 2016 · Recalled
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 7 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 4 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 3 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 2 generations backK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- 1 generation backK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- This deviceK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · cites it directly13descendants
- K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022 · 2 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
- K160513Quanta System Surgical Laser fibersQuanta System Spa · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −8 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −7 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −4 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −3 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| −2 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| −1 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
| +2 | K160513 | Quanta System Surgical Laser fibers | Quanta System Spa | 2016 | 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 |
| 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (17)
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 |
|---|---|---|---|
| * | K972272 | Laser Peripherals Holmium Bare FibersSummary page 2…e 2 === py (2),) Predicate Devices Laser Peripherals Bare Fibers (K(972272) Laser Peripherals Reusable Bare Fibers (1(011207) FiberTech (LEONI) Bare Fibers (single and reusa… | 1997 |
| * | K011207 | Laser Peripherals Reusable Holmium FiberSummary page 2…Predicate Devices Laser Peripherals Bare Fibers (K(972272) Laser Peripherals Reusable Bare Fibers (1(011207) FiberTech (LEONI) Bare Fibers (single and reusable) (K(050738) Lumnenis SlimLineEZ Fiber Delivery Device… | 2001 |
| * | K050738 | FT Fiber Optic Delivery SystemsSummary page 2…(K(972272) Laser Peripherals Reusable Bare Fibers (1(011207) FiberTech (LEONI) Bare Fibers (single and reusable) (K(050738) Lumnenis SlimLineEZ Fiber Delivery Device (1(011703) lnnovaQuartz (AMS) Sure Flex Laser Fiber… | 2005 |
| * | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Summary page 2…(1(011207) FiberTech (LEONI) Bare Fibers (single and reusable) (K(050738) Lumnenis SlimLineEZ Fiber Delivery Device (1(011703) lnnovaQuartz (AMS) Sure Flex Laser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery System… | 2001 |
| * | K050108 | Sureflex and Accuflex Laser Lithotripsy FibersSummary page 2…(K(050738) Lumnenis SlimLineEZ Fiber Delivery Device (1(011703) lnnovaQuartz (AMS) Sure Flex Laser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909… | 2005 |
| * | K934008 | Megabeam Lateral Fire Fiber Optic Delivery SystSummary page 2…(1(011703) lnnovaQuartz (AMS) Sure Flex Laser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080… | 1994 |
| * | K943445 | Megabeam Fiber Optic Delivery SystemSummary page 2…011703) lnnovaQuartz (AMS) Sure Flex Laser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080) BioLite… | 1994 |
| * | K943444 | Megabeam Lateral FireSummary page 2…nnovaQuartz (AMS) Sure Flex Laser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080) BioLitec MegaBeam… | 1994 |
| * | K943526 | Megabeam Lateral Fire Fiber Optic Delivery SystemSummary page 2…z (AMS) Sure Flex Laser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080) BioLitec MegaBeam Endo-ENT-… | 1994 |
| * | K943527 | Megabeam Lateral FireSummary page 2…re Flex Laser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080) BioLitec MegaBeam Endo-ENT-Probe… | 1994 |
| * | K941909 | Mega Beam Lateral FireSummary page 2…ser Fiber (K(050108) Ceramnptec MegaBeam Fiber Laser Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080) BioLitec MegaBeam Endo-ENT-Probe… | 1994 |
| * | K110080 | Radial-Emitting Shaped Fiber Optic Delivery SystemSummary page 2…Delivery Systems (K(934008, K(943445, 1(943444, K(943526, 1(943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080) BioLitec MegaBeam Endo-ENT-Probe (K(113858) Binitec MegaBeam Endocular- and Aspirating Endo… | 2011 |
| * | K113858 | Megabeam Endo-Ent ProbeSummary page 2…943527, K(941909) BioLitec Radial Emitting shaped Fiber Optic delivery System (K(110080) BioLitec MegaBeam Endo-ENT-Probe (K(113858) Binitec MegaBeam Endocular- and Aspirating Endo Probe (1(113792) BARD Medical Holmium Laser Fibers… | 2012 |
| * | K113792 | Megabeam Endocular Probe and Aspirating Endocular ProbeSummary page 2…(K(110080) BioLitec MegaBeam Endo-ENT-Probe (K(113858) Binitec MegaBeam Endocular- and Aspirating Endo Probe (1(113792) BARD Medical Holmium Laser Fibers (K(120926) Fiberoptic Fabrications Laser Delivery System… | 2012 |
| * | K120926 | Endobeam Holmium Laser FibersSummary page 2…(K(113858) Binitec MegaBeam Endocular- and Aspirating Endo Probe (1(113792) BARD Medical Holmium Laser Fibers (K(120926) Fiberoptic Fabrications Laser Delivery System (K(120810) Cynosure SideLaze800 Side Fire Firing Laser del… | 2012 |
| * | K120810 | Fiberoptic Laser Delivery SystemSummary page 2…(1(113792) BARD Medical Holmium Laser Fibers (K(120926) Fiberoptic Fabrications Laser Delivery System (K(120810) Cynosure SideLaze800 Side Fire Firing Laser delivery device (1(121127) Intended Use / Indications of Use The MED-Fi… | 2012 |
| * | K121127 | Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength LasersSummary page 2…(K(120926) Fiberoptic Fabrications Laser Delivery System (K(120810) Cynosure SideLaze800 Side Fire Firing Laser delivery device (1(121127) Intended Use / Indications of Use The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Las… | 2012 |
What descends from it? (23)
See all 233 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 18 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 18 of the 399 ancestors have a recall of any class.
- Of its descendants, K170366 (Laser Peripherals, LLC, 2017) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K972272.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 connector. In…
Read the full statement (335 words)
The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 connector. In addition cleared lasers with SMA 906 connectors. The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery 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. (Diode Laser 532nm-2100nm)
MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue (Diode Laser 532nm-2000nm). MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating/irrigating as an adjunct to vitrectomy surgery. (Diode Laser 532nm-2000nm), Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various vascular tumors (Diode Laser 532nm-2100nm)
MED-Fibers surgical fiber optic delivery device 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 (532nm-2100nm) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124003
Report an extraction error
Are you the manufacturer?
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