# K955758: Indigo Medical Model Idl 830E

- Pathway: 510(k) (Traditional)
- Applicant: Indigo Medical, Inc.
- Decided: Feb 16, 1996 after 59 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
- K982629: Dornier Medilas D (1998), 698 descendants of its own
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own
- K030186: Polris LV (2003), 680 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own

Source page: https://510kreport.com/device/K955758
Methodology: https://510kreport.com/methodology