ELLIPSE I2PL+/ELLIPSE MULTIFLEX+— 510(k) K140670

Substantially Equivalent

Ellipse A/S

FDA 510(k) clearance K140670 for ELLIPSE I2PL+/ELLIPSE MULTIFLEX+, Substantially Equivalent on 2014-09-25. Applicant: Ellipse A/S. Device class: 2.

Clearance details

Applicant: Ellipse A/S
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2014-03-18
Decision date: 2014-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoersholm, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONF

K261204 — Intense Pulsed Light Therapy Device2026-06-12
K251545 — Intense Pulsed Light Therapy Device (MMABM-1)2025-09-04
K231952 — MEDILIGHT2025-09-03
K243123 — IPL Treatment Device (MDSQMC-01)2025-07-03
K250281 — DEKA LOTUS2025-02-26

More clearances from Ellipse A/S

Recalls naming K140670

K-number listed on FDA's recall record

Z-1697-2016 — Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.Class II·Terminated·Ellipse A/S·20160505

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140670.

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