510(k) · Cleared
ClearedLightMed Dental Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightmed Dentaltechnology Corp. · GEX Powered Laser Surgical Instrument
Cleared on Jul 25, 2017 as substantially equivalent to K061966 (Light Instrument, Ltd., 2006) after a 197-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Jul 25, 2017
- Review
- 197 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931783 (1993). 49 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- 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 deviceK170073 LightMed Dental Laser SystemLightmed Dentaltechnology Corp. · 2017
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) | K170073 | LightMed Dental Laser System | Lightmed Dentaltechnology Corp. | 2017 | — |
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 |
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? (1)
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 5…Product code: GEX III. PREDICATE DEVICE Substantial equivalence to the following predicate device is as follows: LITETOUCH Dental Laser System K061966 Decision Date:9/27/2006 IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI- CATION LightMed Dental Laser S… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 49 ancestors have a recall of any class.
- 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. 2017, 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 LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in maxillofacial and cosmetic dentistry. It is intended for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone). The LightMed Dental Laser System is indicated for the following oral and maxillofacial surgery and dentistry: • Hard Tissue Indications of Erbium Laser…
Read the full statement (304 words)
The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in maxillofacial and cosmetic dentistry. It is intended for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).
The LightMed Dental Laser System is indicated for the following oral and maxillofacial surgery and dentistry:
• Hard Tissue Indications of Erbium Laser Energy:
* Caries removal
* Cavity preparation
* Enamel etching
* Excavation of pits and fissures for placement of sealant
• Bone Indications of Erbium Laser Energy:
* 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)
* 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
* 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/K170073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170073: LightMed 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/K170073
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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