# K963969: Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib

- Pathway: 510(k) (Traditional)
- Applicant: Indigo Medical, Inc.
- Decided: Dec 23, 1997 after 446 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.
312 later devices descend from it; 3 cite it directly.
0 of 313 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K955798: Igg Immunoturbidimetric & Calibrator, Randox Laboratories, Ltd. (1996). Our OCR of the scanned summary read K955798, FDA’s number for Igg Immunoturbidimetric & Calibrator (Randox Laboratories, Ltd.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 4.

## Most influential descendants
- K021724: Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems (2002), 305 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own

## Indications for use
Note: Indigo is requesting the expansion of the indications for use which have already been cleared under K955798 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. The expanded Indications for Use will read as follows: The Indigo 830¢ 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 20-85 cc 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/K963969
Methodology: https://510kreport.com/methodology