510(k) · Cleared
ClearedSurgilase Fiberlase VCO2 Laser Waveguide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Products Corp. · GEX Powered Laser Surgical Instrument
Cleared on Jun 18, 1992 after a 71-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 19 later devices descend from it.
- Decided
- Jun 18, 1992
- Review
- 71 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK921671 Surgilase Fiberlase VCO2 Laser WaveguideSurgical Products Corp. · 1992
- Descendant · cites it directly · 14 of its ownK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
- Descendant · cites it directly · 5 of its ownK100384 Fiberlase C02 Laser WaveguideLumenis, Ltd. · 2010
- Descendant · 2 generations on · 5 of its ownK073313 Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK093451 Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low…Omniguide, Inc. · 2009
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005 · cites it directly14descendants
- K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · 2 generations on8descendants
- K100384Fiberlase C02 Laser WaveguideLumenis, Ltd. · 2010 · cites it directly5descendants
- K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008 · 2 generations on5descendants
- K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc. · 2009 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921671 | Surgilase Fiberlase VCO2 Laser Waveguide | Surgical Products Corp. | 1992 | — |
| +1 | K050541 | Omniguide Beampath CO2 Mark I Laser Beam Delivery | Omniguide Communications, Inc. | 2005 | — |
| +2 | K070157 | Omniguide Beam Path CO2 Mark Iii Waveguide Fiber | Omniguide, Inc. | 2007 | 1 |
| +1 | K100384 | Fiberlase C02 Laser Waveguide | Lumenis, Ltd. | 2010 | — |
| +2 | K073313 | Mark Iii Waveguide Fiber with Low Profile Tip | Omniguide, Inc. | 2008 | — |
| +3 | K093451 | Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip | Omniguide, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 4 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (19)
See all 193 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?
- Of its descendants, K050541 (Omniguide Communications, Inc., 2005) has gone furthest, with 14 descendants of its own.
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 | — |
https://510kreport.com/device/K921671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K921671: Surgilase Fiberlase VCO2 Laser Waveguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921671
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026