Cleared Traditional

LAZERSMILE, LAZERWHITE

K000290 · Biolase Technology, Inc. · Dental
Apr 2000
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K000290 is an FDA 510(k) clearance for the LAZERSMILE, LAZERWHITE, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Biolase Technology, Inc. (Clemente, US). The FDA issued a Cleared decision on April 14, 2000, 74 days after receiving the submission on January 31, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number K000290 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2000
Decision Date April 14, 2000
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFW — Toothbrush, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6855

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