EndyMed Contour Handpiece— 510(k) K161199

Name: FDA 510(k) clearance K161199
Creator: U.S. Food and Drug Administration
Published: 2016-08-01

Substantially Equivalent

Endymed Medical, Ltd.

FDA 510(k) clearance K161199 for EndyMed Contour Handpiece, Substantially Equivalent on 2016-08-01. Applicant: Endymed Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Endymed Medical, Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2016-04-28
Decision date: 2016-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

view all

K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

More clearances from Endymed Medical, Ltd.

view all

K242996 — EndyMed PRO MAX2025-06-10
K222369 — PURE Laser2022-10-07
K161715 — EndyGel2017-02-07
DEN150005 — Newa Skin Therapy System2015-12-18
K130501 — INTENSIF2014-03-13

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