# K130420: SOLEA

- Pathway: 510(k) (Traditional)
- Applicant: Convergent Dental, Inc.
- Decided: Jul 12, 2013 after 143 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 11 generations back to K910422 (1992). 163 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123494: SOLEA, Convergent Dental, Inc. (2013) Summary page 2.
- K091746: Waterlase MD, Model 7100102, Biolase Technology, Inc. (2009) Summary page 2.
- K101817: Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E, Model M002-6A/2, Lightwalker ST-N, Fotona D.D. (2010) Summary page 2.

## Most influential descendants
- K151306: Solea (2015), 1 descendant of its own
- K221761: Solea (2022), 0 descendants of its own

## Recalls of this device
- Sep 12, 2013 · Class II · Z-0050-2014: Specific error condition could lead to unintended laser emission during laser activation.

## Indications for use
The Solea system is indicated for the following: Ablation of hard tissue for caries removal and cavity preparation. Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity.

Source page: https://510kreport.com/device/K130420
Methodology: https://510kreport.com/methodology