510(k) · Cleared
ClearedWONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wontech Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 14, 2025 as substantially equivalent to K220189 (Omni-Guide Holdings, Inc., 2022) after a 252-day review. Its family tree reaches back 24 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 14, 2025
- Review
- 252 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 24 generations to K943450 (1995). 403 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations between
- 3 generations backK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- 2 generations backK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- 1 generation backK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
- This deviceK241643 WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK252745 Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261701 Hemolase Fiber…Micro-Energy Medical Technology Co., Ltd. · 2026
Show all 24 generations
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 20 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 19 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 18 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 17 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 16 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 13 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 12 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 11 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 10 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 7 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 6 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 5 generations backK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- 4 generations backK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- 3 generations backK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- 2 generations backK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- 1 generation backK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
- This deviceK241643 WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd. · 2025
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 |
|---|---|---|---|---|---|
| −24 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −23 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −20 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −19 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −18 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −17 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −16 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −13 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −12 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −11 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −10 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −7 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −6 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| −5 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| −4 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| −3 | 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 | — |
| −1 | K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | 2022 | — |
| 0 (this device) | K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. | 2025 | — |
| +1 | K252745 | Halo Sterile Single-use Radial Fiber… | Micro-Energy Medical Technology Co., Ltd. | 2025 | — |
| +2 | K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K220189 | LISA Laser Surgical FibersSummary page 6…) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device 510(k) Number: K220189 Applicant: Omni-Guide Holdings, Inc Classification Name: Powered Laser Surgical Instr… | 2022 |
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 |
|---|---|---|---|
| K252745 | Halo Sterile Single-use Radial Fiber… | 2025 | 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 30 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 18 of the 403 ancestors have a recall of any class.
- Of its descendants, K252745 (Micro-Energy Medical Technology Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K220189.
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?
WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible
laser systems with operational wavelengths between 500nm - 2200nm have received regulatory
clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser
with an SMA 905 connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241643: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241643
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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