510(k) · Cleared
ClearedLitetouch Dental Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Instrument, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 27, 2006 as substantially equivalent to K040270 (Lumenis, Ltd., 2004) and 1 other predicate after a 77-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Sep 27, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931783 (1993). 48 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 5 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 4 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 3 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 2 generations backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- 1 generation backK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- This deviceK061966 Litetouch Dental Laser SystemLight Instrument, Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK073411 LiteduoLight Instruments · 2008
- Descendant · cites it directly · 0 of its ownK170073 LightMed Dental Laser SystemLightmed Dentaltechnology Corp. · 2017
- Descendant · 2 generations on · 0 of its ownK093048 D-Storm 810NM, D-Storm 980NMLight Instruments · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −6 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −5 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −4 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −3 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −2 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| −1 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| 0 (this device) | K061966 | Litetouch Dental Laser System | Light Instrument, Ltd. | 2006 | — |
| +1 | K073411 | Liteduo | Light Instruments | 2008 | — |
| +1 | K170073 | LightMed Dental Laser System | Lightmed Dentaltechnology Corp. | 2017 | — |
| +2 | 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 |
| 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumSummary page 3…including enlargement Predicate Devices: Substantial equivalence to the following predicate devices is claimed: OpusDent Family of Dental K040270 Decision Date: 12/16/2004 Laser Systems Hoya ConBio VersaWaveTM K041710… | 2004 |
| * | K041710 | Versawave Dental ER:Yag Laser SystemSummary page 3…OpusDent Family of Dental K040270 Decision Date: 12/16/2004 Laser Systems Hoya ConBio VersaWaveTM K041710 Decision Date: 08/03/2004 Dental Er:YAG Laser System Performance Standards LITETOUCH… | 2004 |
What descends from it? (3)
2 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 13 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 48 ancestors have a recall of any class.
- Of its descendants, K073411 (Light Instruments, 2008) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K040270.
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 LITETOUCH Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The LITETOUCH 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. This includes the following: Hard Tissue Indications of Erbium Laser…
Read the full statement (314 words)
The LITETOUCH Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The LITETOUCH 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. This includes the following:
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
* 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, 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061966: Litetouch Dental Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061966
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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