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FDA 510(k)

TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER

K-Number: K072995 · 2007-12-18

ApplicantLumen Development and Manufacturing, Inc.
Decision Date2007-12-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Lumen Development and Manufacturing, Inc.. It received FDA 510(k) clearance on 2007-12-18 under 510(k) number K072995. 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 TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER?

TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER is a medical device that received FDA 510(k) clearance on 2007-12-18. The listed applicant is Lumen Development and Manufacturing, Inc.. The 510(k) number is K072995.

When did TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER receive FDA 510(k) clearance?

TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER received FDA 510(k) clearance on 2007-12-18, under 510(k) number K072995.

Who is the listed applicant for TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER?

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

What is the FDA product code for TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER?

The FDA product code for TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER is GEX. This falls under the Gastroenterology category.

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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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