510(k) · Cleared
Recalled · Class II · 2018FT Fiber Optic Delivery Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fibertech GmbH · GEX Powered Laser Surgical Instrument
Cleared on Jun 2, 2005 as substantially equivalent to K923953 (Ceram Optec, Inc., 1992) and 10 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1991. 225 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 2, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 5
- Predicates
- 12
Its longest line of descent runs back 2 generations to K904627 (1991). 34 ancestors in all, the oldest K812219 (1981). 225 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 1 generation backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- This deviceK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 3 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Showing 5 of 225 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 225 · See all- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 3 generations on177descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −1 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| 0 (this device) | K050738 | FT Fiber Optic Delivery Systems | Fibertech GmbH | 2005 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +3 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 10 | 0 |
| 2015 | 11 | 0 |
| 2016 | 11 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 23 | 0 |
| 2023 | 13 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 0 |
| 2026 | 15 | 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? (12)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923953 | MegabeamSummary page 2…rdance with 21 C.F.R. § 878.4810. The product code for the devices are GEX. Predicate Devices Ceramoptec's Fiber Optic Delivery Sytems incl. Handpieces (K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuar… | 1992 |
| * | K943445 | Megabeam Fiber Optic Delivery SystemSummary page 2…th 21 C.F.R. § 878.4810. The product code for the devices are GEX. Predicate Devices Ceramoptec's Fiber Optic Delivery Sytems incl. Handpieces (K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber… | 1994 |
| * | K942182 | Megabeam Dental FiberSummary page 2….R. § 878.4810. The product code for the devices are GEX. Predicate Devices Ceramoptec's Fiber Optic Delivery Sytems incl. Handpieces (K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber Optic Del… | 1994 |
| * | K951775 | Ceralas Diode Laser System (Model Ceralas D50)Summary page 2…10. The product code for the devices are GEX. Predicate Devices Ceramoptec's Fiber Optic Delivery Sytems incl. Handpieces (K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber Optic Delivery System… | 1995 |
| * | K960413 | Coherent Slimline Single Lumen Aspiration Needle KitSummary page 2…cate Devices Ceramoptec's Fiber Optic Delivery Sytems incl. Handpieces (K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber Optic Delivery System (K9940 10), Laser Peripherals Fiber Optic Delivery System (K92272,… | 1996 |
| * | K960032 | Coherent Versapulse Aesthetic Surgical LasersSummary page 2…ces Ceramoptec's Fiber Optic Delivery Sytems incl. Handpieces (K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber Optic Delivery System (K9940 10), Laser Peripherals Fiber Optic Delivery System (K92272, KOl 1207… | 1996 |
| * | K991258 | Novus Verdi Delivery SystemsSummary page 2…tec's Fiber Optic Delivery Sytems incl. Handpieces (K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber Optic Delivery System (K9940 10), Laser Peripherals Fiber Optic Delivery System (K92272, KOl 1207 and K030959… | 1999 |
| * | K994010 | Innovaquartz General Shape Laser FiberSummary page 2…(K923953, K943445, K942182 and K951775), Coherent's Fiber Optic Delivery System incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber Optic Delivery System (K9940 10), Laser Peripherals Fiber Optic Delivery System (K92272, KOl 1207 and K030959), Trymedyne Inc., Fiber Optic Delivery System (K973… | 1999 |
| Kept off the family tree | K092272 | FDA’s K092272 is Randox Methadone Assay Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K011207 | Laser Peripherals Reusable Holmium Fiber | 2001 |
| * | K030959 | Bare Laser Fiber Models DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100Summary page 2…incl. Handpieces (K960413, K960032 and K991258) InnovaQuartz Fiber Optic Delivery System (K9940 10), Laser Peripherals Fiber Optic Delivery System (K92272, KOl 1207 and K030959), Trymedyne Inc., Fiber Optic Delivery System (K973172) Intend of Use The Laser peripherals bare laser fibers, ENT fibers and… | 2003 |
| * | K973172 | Resposable Bare FibersSummary page 2…Quartz Fiber Optic Delivery System (K9940 10), Laser Peripherals Fiber Optic Delivery System (K92272, KOl 1207 and K030959), Trymedyne Inc., Fiber Optic Delivery System (K973172) Intend of Use The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical proce… | 1998 |
What descends from it? (225)
See all 2255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060033 | Profile Multi-Platform System | 2006 | 221 |
| K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and… | 2013 | 23 |
| K131473 | (Quanta System) Surgical Laser Fibers | 2013 | 5 |
| K140366 | Endlessfiber Reusable Surgical Laser Fiber | 2014 | 1 |
| K090281 | Accutech Family of Powerflex Laser Delivery Devices | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2018 | Class II | Z-0579-2019 | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in… |
| Oct 17, 2018 | Class II | Z-0580-2019 | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in… |
| Oct 17, 2018 | Class II | Z-0581-2019 | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in… |
| Oct 17, 2018 | Class II | Z-0577-2019 | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in… |
| Oct 17, 2018 | Class II | Z-0578-2019 | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K060033 (Sciton, Inc, 2006) has gone furthest, with 221 descendants of its own.
- 4 other devices also cite its predicate K923953.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050738 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050738: FT Fiber Optic Delivery Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050738
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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