# Indigo Medical, Inc.

- Location (FDA's records): Palo Alto, CA
- FDA decisions: 6 (1996–1999): 6 510(k) clearances
- Product codes: GEX (5), KXK (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 11 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mick Radio-Nuclear Instruments, Inc.: 1 (https://510kreport.com/company/mick-radio-nuclear-instruments)
- Medi-Physics Inc. Dba Nycomed Amersham Imaging: 1 (https://510kreport.com/company/medi-physics-dba-nycomed-amersham-imaging)

## Firms that cite its devices most
- Ethicon Endo-Surgery, Inc.: 5 (https://510kreport.com/company/ethicon-endo-surgery)
- Biotex, Inc.: 1 (https://510kreport.com/company/biotex)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)
- Trimedyne, Inc.: 1 (https://510kreport.com/company/trimedyne)
- Kelsey, Inc.: 1 (https://510kreport.com/company/kelsey)
- Dornier Surgical Products, Inc.: 1 (https://510kreport.com/company/dornier-surgical-products)

## Its most-cited devices
- K963969: Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib (1997), cited by 3
- K954195: Indigo Portable Laser System, Inddigo Fiberoptics (1996), cited by 2
- K955758: Indigo Medical Model Idl 830E (1996), cited by 2
- K990851: Indigo Laseroptic Treatment System (1999), cited by 2
- K963081: Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications (1997), cited by 2

## Recent decisions
- K992262: Indigo Prostate Seeding Needle Cartridge System (Oct 4, 1999)
- K990851: Indigo Laseroptic Treatment System (Mar 30, 1999)
- K963969: Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power Options : 25, 20, 15 & 10 Watts) Indigo Fib (Dec 23, 1997)
- K963081: Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications (Feb 21, 1997)
- K955758: Indigo Medical Model Idl 830E (Feb 16, 1996)
- K954195: Indigo Portable Laser System, Inddigo Fiberoptics (Jan 25, 1996)

Source page: https://510kreport.com/company/indigo-medical