# K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Dec 16, 2004 after 315 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: 6 generations back to K931783 (1993). 47 ancestors in all.
226 later devices descend from it; 2 cite it directly.
0 of 274 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021508: Opusduo EC Dental Laser System, Opusdent, Ltd. (2002) Summary page 2.
- K032117: Stryker Total Performance (TPS) System, Stryker Instruments (2003) Summary page 1.
- K991696: Stryker Hermes-Ready Total Performance System, Stryker Instruments (1999) Summary page 1.
- K041710: Versawave Dental ER:Yag Laser System, Hoya Conbio (2004). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K040270
Methodology: https://510kreport.com/methodology