BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM— 510(k) K032216

Name: FDA 510(k) clearance K032216
Creator: U.S. Food and Drug Administration
Published: 2004-02-04

Substantially Equivalent

Bioptron AG

FDA 510(k) clearance K032216 for BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM, Substantially Equivalent on 2004-02-04. Applicant: Bioptron AG. Device class: 2.

Clearance details

Applicant: Bioptron AG
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2003-07-21
Decision date: 2004-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHN

view all

K254024 — MR5 Activ Pro2026-05-19
K251903 — Erchonia DPN Laser (Model# EVRL)2026-02-19
K252273 — Therapy US2025-12-12
K241057 — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)2025-01-24
K232813 — Therapy EC, Therapy XT2024-12-19

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