510(k) · Cleared
ClearedOpusduo EC Dental Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opusdent, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 7, 2002 as substantially equivalent to K002899 (Opusdent, Ltd., 2000) and 9 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1992. 240 later devices descend from it.
- Decided
- Aug 7, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K922901 (1992). 29 ancestors in all. 240 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 3 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 2 generations backK991994 TwilightBiolase Technology, Inc. · 1999
- 1 generation backK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- This deviceK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · cites it directly · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 4 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 4 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
Showing 5 of 240 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 240 · See all- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · cites it directly226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 4 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 4 generations on177descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −3 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −2 | K991994 | Twilight | Biolase Technology, Inc. | 1999 | — |
| −1 | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| 0 (this device) | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +1 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +4 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +4 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (10)
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 |
|---|---|---|---|
| * | K002899 | Opus 20, Model 1STSummary page 3…vices. *The technical characteristics of both the Er:YAG and C 0 2 lasers of the OpusDuo EC system are basically the same as those of the cleared Opus 20 6002899) and its new model Opus Spectrum/Opus Duo (KO14100). The Er:YAG component of the OpusDuo EC has the same or very similar… | 2000 |
| * | K014100 | Opus Spectrum (a Model of Opus 20), Model 2ND | 2002 |
| * | K983100 | Kavo Key Laser 1242Summary page 2…equivalent to a combination of the following erbium laser systems cleared by the FDA: KaVo KEY Laser 1242 (KaVo America Corporation) cleared under K983 100 FuturLase 3000/3002 Erbium Laser System (Pharos Optics, Inc.) cleared under K97464 1 Pulsemaster Erbium D… | 1999 |
| * | K974641 | Futurelase 3000/3002 Erbium Laser SystemSummary page 2…KaVo KEY Laser 1242 (KaVo America Corporation) cleared under K983 100 FuturLase 3000/3002 Erbium Laser System (Pharos Optics, Inc.) cleared under K97464 1 Pulsemaster Erbium Dental Laser (American Dental technologies, Inc.) cleared for hard and soft tissues indication… | 1998 |
| * | K012127 | Pulsemaster Erbium Dental Laser System | 2001 |
| * | K961269 | PulsemasterSummary page 2…and soft tissues indications under KO 12127 Pulsemaster Erbium Dental Laser (American Dental technologies, Inc.) cleared for periodontic indication under K961269 WaterLase Millennium Dental Laser System (BioLase Technology, Inc.) cleared under KO1 1041 WaterLase Mi… | 1997 |
| * | K011041 | Waterlase, Millennium | 2001 |
| * | K012511 | Waterlase Millennium | 2002 |
| * | K991297 | Uni-Laser 450P CO2 Laser System & AccessoriesSummary page 2…on of the Opus 20 and Opus Spectrum/Opus Duo cleared under KO02899 and KO14100, respectively, the Uni-CO2 450P C 0 2 Laser System (Medart Corp.), cleared under K991297 and the Opus 1OTM Diode Laser (OpusDent Ltd.) cleared under K000990. Performance Standards: The OpusDuo EC Dental Las… | 1999 |
| * | K000990 | Opus 10 Dental Diode LaserSummary page 2…nd KO14100, respectively, the Uni-CO2 450P C 0 2 Laser System (Medart Corp.), cleared under K991297 and the Opus 1OTM Diode Laser (OpusDent Ltd.) cleared under K000990. Performance Standards: The OpusDuo EC Dental Laser complies with: U.S. Federal Performance Standards 21 CFR 1040.10… | 2000 |
What descends from it? (240)
See all 2402 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?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K040270 (Lumenis, Ltd., 2004) has gone furthest, with 226 descendants of its own.
- 1 other device also cites its predicate K002899.
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 OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue. The Er:YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. These include the following: Soft tissue and periodontal indications 1. Excisional and incisional…
Read the full statement (274 words)
The OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er:YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. These include the following:
Soft tissue and periodontal indications
1. Excisional and incisional biopsies
2. Exposure of unerupted teeth
3. Incision and drainage of abscesses
4. Gingival incision and excision
5. Gingivoplasties
6. Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias
7. Gingival troughing for crown impressions
8. Hemostasis
9. Implant recovery
10. Frenectomies and frenotomies
11. Fibromatosis (fibroma removal)
12. Benign and malignant lesion removal
13. Operculectomy
14. Oral papillectomies
15. Reduction of gingival hypertrophy
16. Soft tissue crown lengthening
17. Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibromatoses, benign growths
18. Vestibuloplasty
19. Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Endodontal applications
• Tooth preparation to obtain access to root canal
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Root canal preparation including enlargement
The CO2 laser component is indicated for periodontal procedures such as removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) and vaporization, incision, excision, coagulation and ablation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021508 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021508: Opusduo EC Dental 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/K021508
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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