510(k) · Cleared
ClearedLiteduo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Instruments · GEX Powered Laser Surgical Instrument
Cleared on May 13, 2008 as substantially equivalent to K061966 (Light Instrument, Ltd., 2006) and 3 other predicates after a 161-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it.
- Decided
- May 13, 2008
- Review
- 161 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K931783 (1993). 60 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 7 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 6 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 5 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 4 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 3 generations backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- 2 generations backK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- 1 generation backK061966 Litetouch Dental Laser SystemLight Instrument, Ltd. · 2006
- This deviceK073411 LiteduoLight Instruments · 2008
- Descendant · cites it directly · 0 of its ownK093048 D-Storm 810NM, D-Storm 980NMLight Instruments · 2010
Most influential descendants
Showing 1 of 1 · See all- K093048D-Storm 810NM, D-Storm 980NMLight Instruments · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −7 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −6 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −5 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −4 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −3 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| −2 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| −1 | K061966 | Litetouch Dental Laser System | Light Instrument, Ltd. | 2006 | — |
| 0 (this device) | K073411 | Liteduo | Light Instruments | 2008 | — |
| +1 | K093048 | D-Storm 810NM, D-Storm 980NM | Light Instruments | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 |
|---|---|---|---|
| * | K061966 | Litetouch Dental Laser SystemSummary page 3…whitening. Predicate Devices: Substantial equivalence to the following predicate devices is claimed: LITETOUCH K06 1966 27 Sep, 2006 SIROLaser K053 161 18 Jan, 2006 Opus 10… | 2006 |
| * | K053161 | SirolaserSummary page 3…ng predicate devices is claimed: LITETOUCH K06 1966 27 Sep, 2006 SIROLaser K053 161 18 Jan, 2006 Opus 10 KOI11769 30 Aug, 2001 Vectra Laser… | 2006 |
| * | K011769 | Opus 10 (with Tooth Whitening Application), Model 2ND | 2001 |
| * | K060114 | Vectra Laser SystemSummary page 3…K053 161 18 Jan, 2006 Opus 10 KOI11769 30 Aug, 2001 Vectra Laser K060114 7 Apr. 2006 Performance Standards LITEDUO Dental Laser System complies with U.S. Federal Performance… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093048 | D-Storm 810NM, D-Storm 980NM | 2010 | 0 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 60 ancestors have a recall of any class.
- Of its descendants, K093048 (Light Instruments, 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061966.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The LiteDuo Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The LiteDuo Dental Laser System 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. In addition, the system is intended for light activation of bleaching…
Read the full statement (396 words)
The LiteDuo Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The LiteDuo Dental Laser System 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. In addition, the system is intended for light activation of bleaching materials for teeth whitening.
This includes the following:
Er:YAG Laser:
Hard Tissue Indications of Erbium Laser Energy:
Caries removal, Cavity preparation, Enamel etching, Enameloplasty, excavation of pits and fissures for placement of sealant.
Bone Indications of Erbium Laser Energy:
Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone), Apicoectomy - amputation of the root end, Cutting bone to prepare a window access to the apex (apices) of the root(s), Osseoplasty, Osteotomy, Osseous crown lengthening
Soft Tissue and Periodontal Indications of Erbium Laser Energy:
Excisional and incisional biopsies, Exposure of unerupted teeth, Incision and drainage of abscesses, Gingival incision and excision, Gingivoplasties, Gingivectornies, 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, papillomas, fibromatoses benign growths, Vestibuloplasty, 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 Indications of Erbium 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.
Diode Laser:
Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073411 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073411: Liteduo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073411
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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