BLUELEX— 510(k) K051203

Substantially Equivalent

Monitex Industrial Co., Ltd.

FDA 510(k) clearance K051203 for BLUELEX, Substantially Equivalent on 2005-05-25. Applicant: Monitex Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Monitex Industrial Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2005-05-11
Decision date: 2005-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBZ

K253131 — Curing Light (M-Cure 6)2026-06-18
K253461 — Demi Pro2025-10-14
K242386 — Bluemoon2025-05-05
K243921 — LED Curing Lights (DB686 HALO)2025-04-11
K250009 — LED Curing Light (C01-X, C02-X)2025-04-10

More clearances from Monitex Industrial Co., Ltd.

K161855 — LED Curing Light2017-11-27
K152192 — LED Curing Light2017-04-07
K153078 — LED Curing Light GT-20002016-06-28
K150205 — LED Curing Light2015-08-24
K133040 — LED CURING LIGHT2014-10-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.