510(k) · Cleared
ClearedSingle Use CO2 Laser Fiber (HAF005001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Feb 19, 2025 as substantially equivalent to K203799 (Innovaquartz, LLC, 2021) after a 91-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Feb 19, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921671 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK921671 Surgilase Fiberlase VCO2 Laser WaveguideSurgical Products Corp. · 1992
- 2 generations backK100384 Fiberlase C02 Laser WaveguideLumenis, Ltd. · 2010
- 1 generation backK203799 ProFlex CO2 Laser FiberInnovaquartz, LLC · 2021
- This deviceK243588 Single Use CO2 Laser Fiber (HAF005001)Quanta System Spa · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921671 | Surgilase Fiberlase VCO2 Laser Waveguide | Surgical Products Corp. | 1992 | — |
| −2 | K100384 | Fiberlase C02 Laser Waveguide | Lumenis, Ltd. | 2010 | — |
| −1 | K203799 | ProFlex CO2 Laser Fiber | Innovaquartz, LLC | 2021 | — |
| 0 (this device) | K243588 | Single Use CO2 Laser Fiber (HAF005001) | Quanta System Spa | 2025 | — |
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 |
|---|---|---|---|
| * | K203799 | ProFlex CO2 Laser FiberSummary page 5…tology. Regulation Number: 21 CFR 878.4810 Product Code: GEX Predicate device ProFlex CO2 Laser Fiber (K203799) manufactured by InnovaQuartz LCC.… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 4 companies; a new generation was cleared every 11.4 years on median.
- None of the 3 ancestors has a recall.
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?
Single Use CO2 Laser Fiber is indicated for the ablation, coagulation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243588: Single Use CO2 Laser Fiber (HAF005001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243588
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