# K963081: Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications

- Pathway: 510(k) (Traditional)
- Applicant: Indigo Medical, Inc.
- Decided: Feb 21, 1997 after 197 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.
36 later devices descend from it; 2 cite it directly.
2 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K053087: Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System (2006), 33 descendants of its own
- K071328: Visualase Thermal Therapy System (2007), 26 descendants of its own
- K081509: Monteris Medical Autolitt Laser Probe (2009), 22 descendants of its own
- K120561: Neuroblate System (2013), 21 descendants of its own
- K131955: Neuroblate (TM) System (2013), 19 descendants of its own

Source page: https://510kreport.com/device/K963081
Methodology: https://510kreport.com/methodology