Indigo Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Indigo Medical, Inc. makes
Indigo Medical, Inc. manufactures laser systems and fiberoptic components for gynecological procedures, including the IDL 830 and IDL 830E laser systems for general gynecological applications, as well as a prostate seed implantation needle cartridge system. Their portfolio also includes portable laser systems with adjustable power options (10–25 watts) and temperature feedback, designed for precision treatment.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance pathway. These products are intended for use in the United States, where they are subject to FDA oversight.
Catalogue
Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems For General Gynecological Applications Ref K963081
Regimes: 510(k) Registry: 510(k)Indigo Prostate Seeding Needle Cartridge System Ref K992262
Regimes: 510(k) Registry: 510(k)Indigo Laseroptic Treatment System Ref K990851
Regimes: 510(k) Registry: 510(k)Indigo Medical Model Idl 830E Ref K955758
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Indigo Medical, Inc. have in the registry?
The registry currently lists 6 devices for Indigo Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Indigo Medical, Inc.'s devices?
Among its 6 most recently registered devices, Indigo Medical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Indigo Medical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Indigo Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Indigo Medical, Inc. in the registry?
The most recently registered devices listed for Indigo Medical, Inc. include INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS, INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM, INDIGO LASEROPTIC TREATMENT SYSTEM and INDIGO MEDICAL MODEL IDL 830E.