# K073411: Liteduo

- Pathway: 510(k) (Traditional)
- Applicant: Light Instruments
- Decided: May 13, 2008 after 161 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931783 (1993). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061966: Litetouch Dental Laser System, Light Instrument, Ltd. (2006) Summary page 3.
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 3.
- K011769: Opus 10 (with Tooth Whitening Application), Model 2ND, Opusdent, Ltd. (2001)
- K060114: Vectra Laser System, Xintec Corporation, Dba, (2006) Summary page 3.

## Most influential descendants
- K093048: D-Storm 810NM, D-Storm 980NM (2010), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K073411
Methodology: https://510kreport.com/methodology