# K994010: Innovaquartz General Shape Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Innovaquartz
- Decided: Dec 17, 1999 after 21 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.
233 later devices descend from it; 5 cite it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050738: FT Fiber Optic Delivery Systems (2005), 225 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
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own

## Indications for use
The InnovaQuartz General Shape Laser Fiber is indicated for use in the vaporization, coagulation, hemostasis and incision of soft tissue. It is designed for use with ND:Yag laser systems, HO: Yag laser systems or Argon laser systems which have been cleared for medical use and accept SMA 905 connectors.

Source page: https://510kreport.com/device/K994010
Methodology: https://510kreport.com/methodology