# K990851: Indigo Laseroptic Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Indigo Medical, Inc.
- Decided: Mar 30, 1999 after 15 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
Longest line of descent: 1 generation back to K963969 (1997). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963969: Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib, Indigo Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K022655: Trimedyne Side Firing Needle with Vent Sheath (2002), 3 descendants of its own
- K050412: Vapormax (2005), 2 descendants of its own
- K053457: Vapormax II (2005), 1 descendant of its own
- K013493: Indigo Optima Laser System (2001), 1 descendant of its own
- K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD (2024), 0 descendants of its own

## Indications for use
The Indigo LaserOptic™ Treatment System with Diffuser-Tip™ Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 20-85cc and for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.

Source page: https://510kreport.com/device/K990851
Methodology: https://510kreport.com/methodology