# K974641: Futurelase 3000/3002 Erbium Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Buckman Co., Inc.
- Decided: Jun 8, 1998 after 175 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: 2 generations back to K954013 (1996). 4 ancestors in all.
241 later devices descend from it; 1 cites it directly.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996) Summary page 1.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.
- K970934: CB Erbium/2.94(TM) ER:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 3.
- K922901: Incisor I Pulsed ND:Yag Laser System, Buckman Co., Inc. (1992) Summary page 1.

## Most influential descendants
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
For use in oral/dental procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue. Gingivoplasties Gingivectomies Frenectomies Benign and malignant lesion removal Biopsies Leukoplakia Fibrotomy

Source page: https://510kreport.com/device/K974641
Methodology: https://510kreport.com/methodology