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FDA 510(k)

DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER

K-Number: K992013 · 1999-09-08

ApplicantContinuum Biomedical, Inc.
Decision Date1999-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Biomedical, Inc.. It received FDA 510(k) clearance on 1999-09-08 under 510(k) number K992013. 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 DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER?

DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K992013.

When did DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER receive FDA 510(k) clearance?

DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER received FDA 510(k) clearance on 1999-09-08, under 510(k) number K992013.

Who is the listed applicant for DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER?

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

What is the FDA product code for DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER?

The FDA product code for DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER is GEX. This falls under the Gastroenterology category.

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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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