# K863642: Candela Model MDL-1 Laser Lithotriptor

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Dec 3, 1986 after 77 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 1 cites it directly.
0 of 24 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
- K963285: Ems Swiss Lithoclast Lithotripter (1997), 22 descendants of its own
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) (2001), 15 descendants of its own
- K052135: Cybersonics Cyberwand Dual Probe Lithotripter (2005), 6 descendants of its own
- K173234: Swiss LithoClast Trilogy (2018), 5 descendants of its own
- K102169: Cyberwand Lithotripter (2010), 5 descendants of its own

Source page: https://510kreport.com/device/K863642
Methodology: https://510kreport.com/methodology