# K000317: Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Medical Lasers, Inc.
- Decided: Oct 27, 2000 after 269 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.
240 later devices descend from it; 3 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053139: Fotona QX ND:Yag/KTP Laser System (2006), 168 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own
- K103455: Spectra Laser System (2011), 92 descendants of its own
- K113588: Spectra Laser System (2012), 82 descendants of its own
- K033259: Light Age Q-Clear Laser, Model 701-1101 (2004), 76 descendants of its own

Source page: https://510kreport.com/device/K000317
Methodology: https://510kreport.com/methodology