UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL— 510(k) K134009

Name: FDA 510(k) clearance K134009
Creator: U.S. Food and Drug Administration
Published: 2014-10-15

Substantially Equivalent

Medtek Lighting

FDA 510(k) clearance K134009 for UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL, Substantially Equivalent on 2014-10-15. Applicant: Medtek Lighting. Device class: 2.

Clearance details

Applicant: Medtek Lighting
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2013-12-30
Decision date: 2014-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTC

view all

K254234 — Phototherapy System (DUV-COMBO)2026-05-01
K253871 — Klär Lite (RCW-KL1000)2026-03-04
K250425 — Ultraviolet Phototherapy Device2025-04-07
K244022 — 308nm UV Phototherapy System (4 models)2025-03-13
K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)2025-02-06

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