# K010104: Candela Long Pulse ND:Yag

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Apr 11, 2001 after 89 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.
741 later devices descend from it; 6 cite it directly.
0 of 742 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
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 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
- K022951: Candela Gentle Yag Laser System, Variable Pulse Yag (2003), 657 descendants of its own
- K022923: Candela Gentle Yag Laser System (2003), 656 descendants of its own
- K023193: Candela Gentle Yag Laser System (2002), 656 descendants of its own

Source page: https://510kreport.com/device/K010104
Methodology: https://510kreport.com/methodology