# K011092: Candela SPTL-1E Pulsed Dye Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jul 9, 2001 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.
1,127 later devices descend from it; 3 cite it directly.
0 of 1,128 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
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems (2003), 756 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own

Source page: https://510kreport.com/device/K011092
Methodology: https://510kreport.com/methodology