Cleared Traditional

K070523 - MODIFICATION TO: VELSCOPE
(FDA 510(k) Clearance)

K070523 · Led Dental, Inc. · Dental
Apr 2007
Decision
41d
Days
Class 2
Risk

K070523 is an FDA 510(k) clearance for the MODIFICATION TO: VELSCOPE. This device is classified as a Diagnostic Light, Soft Tissue Detector (Class II — Special Controls, product code NXV).

Submitted by Led Dental, Inc. (White Rock, British Columbia, CA). The FDA issued a Cleared decision on April 5, 2007, 41 days after receiving the submission on February 23, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6350. To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities.

Submission Details

510(k) Number K070523 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2007
Decision Date April 05, 2007
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NXV — Diagnostic Light, Soft Tissue Detector
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6350
Definition To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities