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FDA 510(k)

INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS

K-Number: K954195 · 1996-01-25

ApplicantIndigo Medical, Inc.
Decision Date1996-01-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS is the device name listed in this FDA 510(k) record. The listed applicant is Indigo Medical, Inc.. It received FDA 510(k) clearance on 1996-01-25 under 510(k) number K954195. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS?

INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is Indigo Medical, Inc.. The 510(k) number is K954195.

When did INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS receive FDA 510(k) clearance?

INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS received FDA 510(k) clearance on 1996-01-25, under 510(k) number K954195.

Who is the listed applicant for INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS?

The FDA 510(k) record lists Indigo Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS?

The FDA product code for INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS is GEX. This falls under the Gastroenterology category.

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Other records listing Indigo Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992262INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEMK990851INDIGO LASEROPTIC TREATMENT SYSTEMK963969INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIBK963081INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONSK955758INDIGO MEDICAL MODEL IDL 830E

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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