# K141838: Sol Portable Diode Laser Unit (with Wireless Foot Control)

- Pathway: 510(k) (Traditional)
- Applicant: Regulatory Technology Services, LLC
- Decided: Jul 25, 2014 after 17 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: 9 generations back to K922901 (1992). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103667: Sapphire ST Portable Diode Laser, Den-Mat Holdings, LLC (2010) Summary page 2.
- K102639: SL3, Discus Dental, LLC (2010) Summary page 2.

## Indications for use
The SQL Portable Diode Laser Unit (with wireless foot control) is intended for use in dental intracoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; fnectomay; frenotomy; gingival incision and excision; gingivectomy; gingivoplast; incising and draining abscesses; opercuiectomy; oral papillectoiny; removal of fibromas; soft tissue crown lengthening; suilcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibulopiasty.

Source page: https://510kreport.com/device/K141838
Methodology: https://510kreport.com/methodology