# K013493: Indigo Optima Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Dec 13, 2001 after 52 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: 2 generations back to K963969 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K954195: Indigo Portable Laser System, Inddigo Fiberoptics, Indigo Medical, Inc. (1996) Summary page 1.
- K955758: Indigo Medical Model Idl 830E, Indigo Medical, Inc. (1996) Summary page 1.
- K963081: Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications, Indigo Medical, Inc. (1997) Summary page 1.
- K990851: Indigo Laseroptic Treatment System, Indigo Medical, Inc. (1999) Summary page 1.
- K003952: Indigo Laseroptic Treatment System, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K003953: Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.

## Most influential descendants
- K023182: Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip Fiberoptic,Optima Laser Cart with Prints (2002), 0 descendants of its own

## Indications for use
The indigo OPTIMA Laser 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 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids. The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.

Source page: https://510kreport.com/device/K013493
Methodology: https://510kreport.com/methodology