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FDA 510(k)

DIO-DENT 10 DENTAL DIODE LASER

K-Number: K031819 · 2003-10-30

ApplicantMsq (M2) , Ltd.
Decision Date2003-10-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIO-DENT 10 DENTAL DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Msq (M2) , Ltd.. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K031819. 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 DIO-DENT 10 DENTAL DIODE LASER?

DIO-DENT 10 DENTAL DIODE LASER is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Msq (M2) , Ltd.. The 510(k) number is K031819.

When did DIO-DENT 10 DENTAL DIODE LASER receive FDA 510(k) clearance?

DIO-DENT 10 DENTAL DIODE LASER received FDA 510(k) clearance on 2003-10-30, under 510(k) number K031819.

Who is the listed applicant for DIO-DENT 10 DENTAL DIODE LASER?

The FDA 510(k) record lists Msq (M2) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIO-DENT 10 DENTAL DIODE LASER?

The FDA product code for DIO-DENT 10 DENTAL DIODE LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Msq (M2) , Ltd. 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.

K052874SOPRANO HAIR REMOVAL DIODE LASERK042000MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMSK033946LOVELY SYSTEMK030805MYTHOS 500

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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