510(k) · Cleared
ClearedOpusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Dec 16, 2004 as substantially equivalent to K021508 (Opusdent, Ltd., 2002) and 3 other predicates after a 315-day review. Its family tree reaches back 6 generations to 1993. 226 later devices descend from it.
- Decided
- Dec 16, 2004
- Review
- 315 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K931783 (1993). 47 ancestors in all, the oldest K771218 (1978). 226 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 3 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 2 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 1 generation backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- This deviceK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 3 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Showing 5 of 226 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 226 · See all- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 3 generations on177descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −5 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −4 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −3 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −2 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −1 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| 0 (this device) | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +3 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 23 | 0 |
| 2023 | 13 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 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 |
|---|---|---|---|
| * | K021508 | Opusduo EC Dental Laser SystemSummary page 2…pplications to the predicate OpusDent Duo, OpusDent 20, and OpusDent Spectra (K021508), the Stryker Total Performance System (TIS)… | 2002 |
| * | K032117 | Stryker Total Performance (TPS) SystemSummary page 1…strument mR. Predicate Devices * OpusDent Duo, OpusDent 20, and OpusDent Spectra (KO2 1508) * Stryker Total Performance System (TPS) (K032117 and K991696) * I-Ioya Conbio VersaWave Dental Er:YAOGLaser System (K041710) IV. Product Description… | 2003 |
| * | K991696 | Stryker Hermes-Ready Total Performance SystemSummary page 1…mR. Predicate Devices * OpusDent Duo, OpusDent 20, and OpusDent Spectra (KO2 1508) * Stryker Total Performance System (TPS) (K032117 and K991696) * I-Ioya Conbio VersaWave Dental Er:YAOGLaser System (K041710) IV. Product Description The Opus… | 1999 |
| * | K041710 | Versawave Dental ER:Yag Laser System Cleared while this submission was under review Summary page 1…sDent Spectra (KO2 1508) * Stryker Total Performance System (TPS) (K032117 and K991696) * I-Ioya Conbio VersaWave Dental Er:YAOGLaser System (K041710) IV. Product Description The OpusDent Family of Dental Laser Systems is comprised of the following main… | 2004 |
What descends from it? (226)
See all 2262 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 11 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 47 ancestors have a recall of any class.
- Of its descendants, K060033 (Sciton, Inc, 2006) has gone furthest, with 221 descendants of its own.
- 1 other device also cites its predicate K021508.
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 OpusDent Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The Er:YAG laser component is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following: Hard Tissue Indications of Er:YAG Laser Energy *…
Read the full statement (413 words)
The OpusDent Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The Er:YAG laser component is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.
This includes the following:
Hard Tissue Indications of Er:YAG Laser Energy
* Caries removal
* Cavity preparation
* Enamel etching
* Enameloplasty, excavation of pits and fissures for placement of sealant
Bone Indications of Er:YAG Laser Energy
* Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone)
* Apicoectomy - amputation of the root end
* Osseous crown lengthening
* Cutting bone to prepare a window access to the apex (apices) of the root(s)
* Osseoplasty
* Osteotomy
Soft Tissue and Periodontal Indications of Er:YAG Laser Energy
* Excisional and incisional biopsies
* Exposure of unerrupted teeth
* Incision and drainage of abscesses
* Gingival incision and excision
* Gingivoplasties
* Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias
* Gingival troughing for crown impressions
* Hemostasis
* Implant recovery
* Frenectomies and frenotomies
* Fibromatosis (fibroma removal)
* Benign and malignant lesion removal
* Operculectomy
* Oral papillectomies
* Reduction of gingival hypertrophy
* Soft tissue crown lengthening
* Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibromatoses, benign growths
* Vestibuloplasty
* Sucular 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 of Er:YAG Laser Energy:
* Tooth preparation to obtain access to root canal
* Pulpotomy, Pulpotomy as an adjunct to root canal therapy
* Pulp extirpation
* Root canal debridement and cleaning
* Root canal preparation including enlargement
The CO2 laser component is indicated for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in a variety of soft tissue applications, and in oral and maxillofacial surgery and dentistry.
Periodontal Applications of CO2 Laser Energy:
* Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement)
* Biopsies
* Frenectomy, Frenum release
* Gingivectomy
* Gingivoplasty
* Papillectomy
* Vestibuloplasty
* Hyperplasia
* Operculectomy
* Drainage (abscess)
* Flap surgery
* Fibroma (nonmalignant tumor; mucosa, tongue)
* Epulis (tumor of the gum)
* Aphthous ulcers
* Removal of soft tissue, cysts, and tumors
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040270
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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