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FDA 510(k)

SPECTRA PULSED DIODE LASER, MODEL DR-1

K-Number: K032846 · 2003-12-11

ApplicantSpectragenics, Inc.
Decision Date2003-12-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA PULSED DIODE LASER, MODEL DR-1 is the device name listed in this FDA 510(k) record. The listed applicant is Spectragenics, Inc.. It received FDA 510(k) clearance on 2003-12-11 under 510(k) number K032846. 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 SPECTRA PULSED DIODE LASER, MODEL DR-1?

SPECTRA PULSED DIODE LASER, MODEL DR-1 is a medical device that received FDA 510(k) clearance on 2003-12-11. The listed applicant is Spectragenics, Inc.. The 510(k) number is K032846.

When did SPECTRA PULSED DIODE LASER, MODEL DR-1 receive FDA 510(k) clearance?

SPECTRA PULSED DIODE LASER, MODEL DR-1 received FDA 510(k) clearance on 2003-12-11, under 510(k) number K032846.

Who is the listed applicant for SPECTRA PULSED DIODE LASER, MODEL DR-1?

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

What is the FDA product code for SPECTRA PULSED DIODE LASER, MODEL DR-1?

The FDA product code for SPECTRA PULSED DIODE LASER, MODEL DR-1 is GEX. This falls under the Gastroenterology category.

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Other records listing Spectragenics, 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.

K090820TRIA HAIR REMOVAL LASER SYSTEMK053527SPECTRA HAIR REMOVAL LASERK060567SPECTRAGENICS ATS-1K052848SPECTRA HAIR REMOVAL LASER

Related Devices (Code: GEX)

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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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