# K221761: Solea

- Pathway: 510(k) (Traditional)
- Applicant: Convergent Dental, Inc.
- Decided: Sep 14, 2022 after 89 days
- Product code: NVK (Laser, Dental, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K910422 (1992). 165 ancestors in all.
No later device cites it as a predicate yet.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151306: Solea, Convergent Dental, Inc. (2015) Summary page 4.

## Recalls of this device
- Sep 1, 2023 · Class II · Z-0324-2024: It has been found that potential unintended laser activation can occur without foot pedal depression.

## Indications for use
The Solea system is indicated for the following: • Ablation of hard tissue for caries removal and cavity prevention • Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity • Cutting, shaving, contouring and resection of oral osseous tissue (both) • Aiding in the reduction of mineral loss in dental enamel

Source page: https://510kreport.com/device/K221761
Methodology: https://510kreport.com/methodology