510(k) · Cleared
ClearedFuturelase 3000/3002 Erbium Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buckman Co., Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 8, 1998 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) and 3 other predicates after a 175-day review. Its family tree reaches back 2 generations to 1996. 241 later devices descend from it.
- Decided
- Jun 8, 1998
- Review
- 175 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K954013 (1996). 4 ancestors in all, the oldest K922901 (1992). 241 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 1 generation backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- This deviceK974641 Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
- Descendant · cites it directly · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 241 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 241 · See all- K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · cites it directly240descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −1 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| 0 (this device) | K974641 | Futurelase 3000/3002 Erbium Laser System | Buckman Co., Inc. | 1998 | — |
| +1 | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +2 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +4 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 10 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 13 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 24 | 0 |
| 2023 | 14 | 0 |
| 2024 | 24 | 0 |
| 2025 | 29 | 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? (4)
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 |
|---|---|---|---|
| * | K954013 | Trilase 2940 Erbium LaserSummary page 1…g Products. See 21 CFR §1040.10, Laser products. 6. Substantially Equivalent Device(s): 1. TriLase 2940 Erbium Laser System, Schwartz Electro-Optics, Inc. (SEO Medical, K954013) 2. MedLite Erbium Laser System, Continuum Biomedical, Inc., K961748, & K9870934. 3. PulseMaster™ Dental Laser System, K922901… | 1996 |
| * | K961748 | Medlite/Erbium Laser SystemSummary page 1…uivalent Device(s): 1. TriLase 2940 Erbium Laser System, Schwartz Electro-Optics, Inc. (SEO Medical, K954013) 2. MedLite Erbium Laser System, Continuum Biomedical, Inc., K961748, & K9870934. 3. PulseMaster™ Dental Laser System, K922901 FurtureLase jo00/3002 Erbivm Laser System 99 7. Devic… | 1996 |
| * | K970934 | CB Erbium/2.94(TM) ER:Yag LaserSummary page 3…12 | 220 VAC, 20 Amps 50/60 Hz, Amps max, 50/60 Hz Amps max, 50/60 Hz single phase Indication Dental/Oral soft tissue Dental Dental K Number K974641 K961748 - K970934 K854013 FueureLase z3000/3002 Erbiuimn Laser Syscem o WEALTH & ¥ SERVICE, o S % % DEPARTMENT OF HEALTH & HU… | 1997 |
| * | K922901 | Incisor I Pulsed ND:Yag Laser SystemSummary page 1…hwartz Electro-Optics, Inc. (SEO Medical, K954013) 2. MedLite Erbium Laser System, Continuum Biomedical, Inc., K961748, & K9870934. 3. PulseMaster™ Dental Laser System, K922901 FurtureLase jo00/3002 Erbivm Laser System 99 7. Device Description: Pharos Optics, Inc. offers a dental laser s… | 1992 |
What descends from it? (241)
See all 2411 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021508 | Opusduo EC Dental Laser System | 2002 | 240 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K021508 (Opusdent, Ltd., 2002) has gone furthest, with 240 descendants of its own.
- 13 other devices also cite its predicate K954013.
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?
For use in oral/dental procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue.
Gingivoplasties
Gingivectomies
Frenectomies
Benign and malignant lesion removal
Biopsies
Leukoplakia
Fibrotomy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974641 · printed Nov 3, 2026
Cite this page
510(k) Report. “K974641: Futurelase 3000/3002 Erbium Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K974641
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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