# K021508: Opusduo EC Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Opusdent, Ltd.
- Decided: Aug 7, 2002 after 90 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: 4 generations back to K922901 (1992). 29 ancestors in all.
240 later devices descend from it; 2 cite it directly.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002899: Opus 20, Model 1ST, Opusdent, Ltd. (2000) Summary page 3.
- K014100: Opus Spectrum (a Model of Opus 20), Model 2ND, Opusdent, Ltd. (2002)
- K983100: Kavo Key Laser 1242, Kavo America (1999) Summary page 2.
- K974641: Futurelase 3000/3002 Erbium Laser System, Buckman Co., Inc. (1998) Summary page 2.
- K012127: Pulsemaster Erbium Dental Laser System, American Dental Technologies, Inc. (2001)
- K961269: Pulsemaster, American Dental Technologies, Inc. (1997) Summary page 2.
- K011041: Waterlase, Millennium, Biolase Technology, Inc. (2001)
- K012511: Waterlase Millennium, Biolase Technology, Inc. (2002)
- K991297: Uni-Laser 450P CO2 Laser System & Accessories, Medart Corp. (1999) Summary page 2.
- K000990: Opus 10 Dental Diode Laser, Opusdent, Ltd. (2000) Summary page 2.

## Most influential descendants
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- 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

## Indications for use
The OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue. The Er:YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. These include the following: Soft tissue and periodontal indications 1. Excisional and incisional biopsies 2. Exposure of unerupted teeth 3. Incision and drainage of abscesses 4. Gingival incision and excision 5. Gingivoplasties 6. Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias 7. Gingival troughing for crown impressions 8. Hemostasis 9. Implant recovery 10. Frenectomies and frenotomies 11. Fibromatosis (fibroma removal) 12. Benign and malignant lesion removal 13. Operculectomy 14. Oral papillectomies 15. Reduction of gingival hypertrophy 16. Soft tissue crown lengthening 17. Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibromatoses, benign growths 18. Vestibuloplasty 19. 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 applications • Tooth preparation to obtain access to root canal • Pulpotomy • Pulp extirpation • Pulpotomy as an adjunct to root canal therapy • Root canal debridement and cleaning • Root canal preparation including enlargement The CO2 laser component is indicated for periodontal procedures such as removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) and vaporization, incision, excision, coagulation and ablation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.

Source page: https://510kreport.com/device/K021508
Methodology: https://510kreport.com/methodology