# K014100: Opus Spectrum (a Model of Opus 20), Model 2ND

- Pathway: 510(k) (Special)
- Applicant: Opusdent, Ltd.
- Decided: Jan 8, 2002 after 26 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: 1 generation back to K002899 (2000). 1 ancestor in all.
241 later devices descend from it; 1 cites it directly.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002899: Opus 20, Model 1ST, Opusdent, Ltd. (2000) 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
The OpuDuo Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue. The Er:YAG laser component is indicated for caries removal, cavity preparation, and enamel etching. The CO, laser component is indicated for vaporization, incision, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.

Source page: https://510kreport.com/device/K014100
Methodology: https://510kreport.com/methodology