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FDA 510(k)

CURATIVE980 DIODE LASER

K-Number: K082445 · 2008-10-15

ApplicantOroscience, Inc.
Decision Date2008-10-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CURATIVE980 DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Oroscience, Inc.. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K082445. 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 CURATIVE980 DIODE LASER?

CURATIVE980 DIODE LASER is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Oroscience, Inc.. The 510(k) number is K082445.

When did CURATIVE980 DIODE LASER receive FDA 510(k) clearance?

CURATIVE980 DIODE LASER received FDA 510(k) clearance on 2008-10-15, under 510(k) number K082445.

Who is the listed applicant for CURATIVE980 DIODE LASER?

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

What is the FDA product code for CURATIVE980 DIODE LASER?

The FDA product code for CURATIVE980 DIODE LASER is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Oroscience, 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.

K083516PERIOGENIX

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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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