# K002421: Candela Mid IR Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Nov 3, 2000 after 87 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.
744 later devices descend from it; 2 cite it directly.
0 of 745 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
- K013825: Candela Smoothbeam Laser System (2002), 740 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
- K022884: Candela Smoothbeam Laser System (2003), 642 descendants of its own
- K030834: Candela Smoothbeam Laser System (2003), 603 descendants of its own
- K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System (2004), 569 descendants of its own

Source page: https://510kreport.com/device/K002421
Methodology: https://510kreport.com/methodology