# K123494: SOLEA

- Pathway: 510(k) (Traditional)
- Applicant: Convergent Dental, Inc.
- Decided: Feb 11, 2013 after 90 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: 8 generations back to K936109 (1994). 58 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091320: Spectra SP II, Spectra Denta II, Lutronic Corporation (2009) Summary page 1.

## Most influential descendants
- K130420: SOLEA (2013), 2 descendants of its own
- 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: * Incision * Excision * Vaporization * Coagulation * Hernostasis of soft tissue in the oral cavity.

Source page: https://510kreport.com/device/K123494
Methodology: https://510kreport.com/methodology