# K140120: EPIC 10

- Pathway: 510(k) (Traditional)
- Applicant: Biolase, Inc.
- Decided: Oct 10, 2014 after 267 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: 18 generations back to K943450 (1995). 362 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 364 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 4.
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 4.
- K060114: Vectra Laser System, Xintec Corporation, Dba, (2006) Summary page 4.

## Most influential descendants
- K161185: LUCERNA Dental Laser (2016), 0 descendants of its own

## Indications for use
The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use: General Surgery, Dermatology, Plastic Surgery and Podiatry • Debridement of wounds

Source page: https://510kreport.com/device/K140120
Methodology: https://510kreport.com/methodology