LED PROLUX 770— 510(k) K061695

Substantially Equivalent

Peng Lim Enterprise Co., Ltd.

FDA 510(k) clearance K061695 for LED PROLUX 770, Substantially Equivalent on 2006-09-14. Applicant: Peng Lim Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant: Peng Lim Enterprise Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2006-06-15
Decision date: 2006-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung, 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 Peng Lim Enterprise Co., Ltd.

K062947 — HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES2006-12-14

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