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FDA 510(k)

APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM

K-Number: K955007 · 1996-01-26

ApplicantApplied Optronics Corp.
Decision Date1996-01-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Optronics Corp.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K955007. 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 APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM?

APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Applied Optronics Corp.. The 510(k) number is K955007.

When did APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM receive FDA 510(k) clearance?

APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM received FDA 510(k) clearance on 1996-01-26, under 510(k) number K955007.

Who is the listed applicant for APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM?

The FDA 510(k) record lists Applied Optronics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM?

The FDA product code for APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Applied Optronics Corp. 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.

K961705AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEMK961710AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEMK955014APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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