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FDA 510(k)

SPPHINE PLUS STM 3W DIODE LASER

K-Number: K110079 · 2011-02-10

ApplicantDen-Mat Holdings, LLC
Decision Date2011-02-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPPHINE PLUS STM 3W DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2011-02-10 under 510(k) number K110079. 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 SPPHINE PLUS STM 3W DIODE LASER?

SPPHINE PLUS STM 3W DIODE LASER is a medical device that received FDA 510(k) clearance on 2011-02-10. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K110079.

When did SPPHINE PLUS STM 3W DIODE LASER receive FDA 510(k) clearance?

SPPHINE PLUS STM 3W DIODE LASER received FDA 510(k) clearance on 2011-02-10, under 510(k) number K110079.

Who is the listed applicant for SPPHINE PLUS STM 3W DIODE LASER?

The FDA 510(k) record lists Den-Mat Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPPHINE PLUS STM 3W DIODE LASER?

The FDA product code for SPPHINE PLUS STM 3W DIODE LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Den-Mat Holdings, LLC as applicant

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Official Source

View on FDA Database →

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

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