# K970934: CB Erbium/2.94(TM) ER:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: Jun 11, 1997 after 90 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
No predicates in its family tree.
304 later devices descend from it; 4 cite it directly.
0 of 305 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Schwartz Electro-Optics TriLase 2940: named in the summary without a submission number
- (no number) Coherent UltraPulse CO2 Laser: named in the summary without a submission number

## Most influential descendants
- K974641: Futurelase 3000/3002 Erbium Laser System (1998), 241 descendants of its own
- 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

## Indications for use
For skin resurfacing in the treatment of wrinkles

Source page: https://510kreport.com/device/K970934
Methodology: https://510kreport.com/methodology