# K011769: Opus 10 (with Tooth Whitening Application), Model 2ND

- Pathway: 510(k) (Traditional)
- Applicant: Opusdent, Ltd.
- Decided: Aug 30, 2001 after 84 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
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Opus 10™ Dental Diode Laser System: named in the summary without a submission number
- (no number) Twilite™ Dental Diode Laser system: named in the summary without a submission number
- (no number) Aurora™ Diode Laser System: named in the summary without a submission number
- (no number) Dentek™ LD 15 Diode laser: named in the summary without a submission number

## Most influential descendants
- K083034: Fotona XD-2 Diode Laser System, Model MD01-2F (2009), 13 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K240179: Medical Diode Laser (Model: L2) (2024), 2 descendants of its own
- K230274: Medical Diode Laser (M2) (2023), 2 descendants of its own

## Indications for use
The Opus 10™ Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulatien (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Opus 10™ Dental Diode Laser System include: Cosmetic Dentistry « Light activation for bleaching materials for teeth whitening « Laser-assisted bleaching/whitening of the teeth Endodontology e Pulpotomy + Pulpotomy as an adjunct to root canal therapy Periodontology « Sulcular debridement (removal of diseased or inflamed soft tissue n the periodental pocket) Oral Soft Tissue Surgery * Biopsy » Qperculectomy » Gingivectomy » Gingivoplasty « Papillectomy Lesion (tumor) removal » Leukoplakia Treatment of aphthous ulcers » Fibroma removal * Frenectomies and frenotomies + Tissue retraction for impressions » Incising and draining of abscesses » Exposure of unerupted teeth

Source page: https://510kreport.com/device/K011769
Methodology: https://510kreport.com/methodology