510(k) · Cleared
Recalled · 2010Fiber One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems · GEX Powered Laser Surgical Instrument
Cleared on Jun 11, 2010 as substantially equivalent to K062719 (Laserscope, 2006) after an 87-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 11, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062719 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006 · Recalled
- This deviceK100746 Fiber OneAmerican Medical Systems · 2010
- Descendant · cites it directly · 1 of its ownK120870 Greenlight Moxy Fiber OpticAmerican Medical Systems · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK202601 Single-use Sterile medical laser fiberRealton (Suzhou) Medical Technology Co., Ltd. · 2020
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 |
|---|---|---|---|---|---|
| −1 | K062719 | Greenlight HPS Series Surgical Laser System & Accessories | Laserscope | 2006 | 5 |
| 0 (this device) | K100746 | Fiber One | American Medical Systems | 2010 | — |
| +1 | K120870 | Greenlight Moxy Fiber Optic | American Medical Systems | 2012 | 1 |
| +2 | K202601 | Single-use Sterile medical laser fiber | Realton (Suzhou) Medical Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K062719 | Greenlight HPS Series Surgical Laser System & AccessoriesSummary page 2…5 10(k) PREMARKET NOTIFICATION SECTION 5 510(k) SUMMARY (CONT.) PREDICATE DEVICE Fiber One is substantially equivalent to the 2090 Fiber (K0627 19). The 2090 Fiber is a fiber optic delivery device that was cleared as an accessory with the GreenLight HPS Surgical Laser System… | 2006 |
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 |
|---|---|---|---|
| K120870 | Greenlight Moxy Fiber Optic | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2010 | Not classified | Z-0834-2011 | Labeling mix-ups | Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Fiber One is a fiber optic delivery device intended for use with the GreenLight Laser System for its FDA cleared indications for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100746: Fiber One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100746
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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