# K954934: Candela SPTL Long Pulse/Tunable Pulsed Dye Lase

- Pathway: 510(k) (Traditional)
- Applicant: Candela Laser Corp.
- Decided: Feb 2, 1996 after 98 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.
701 later devices descend from it; 2 cite it directly.
0 of 702 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
- K993671: Candela Sclero Long Pulse Dye Laser (2000), 700 descendants of its own
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam) (2002), 699 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own

Source page: https://510kreport.com/device/K954934
Methodology: https://510kreport.com/methodology