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FDA 510(k)

LUMAPROBE

K-Number: K073000 · 2008-10-01

ApplicantClareblend, Inc.
Decision Date2008-10-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMAPROBE is the device name listed in this FDA 510(k) record. The listed applicant is Clareblend, Inc.. It received FDA 510(k) clearance on 2008-10-01 under 510(k) number K073000. 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 LUMAPROBE?

LUMAPROBE is a medical device that received FDA 510(k) clearance on 2008-10-01. The listed applicant is Clareblend, Inc.. The 510(k) number is K073000.

When did LUMAPROBE receive FDA 510(k) clearance?

LUMAPROBE received FDA 510(k) clearance on 2008-10-01, under 510(k) number K073000.

Who is the listed applicant for LUMAPROBE?

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

What is the FDA product code for LUMAPROBE?

The FDA product code for LUMAPROBE is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Clareblend, 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.

K073022CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830K880553ELECTRONIC EPILATOR

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

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