INTRAGen

FDA 510(k) K142833 · Jeisys Medical, Inc.

Substantially Equivalent

510(k) numberK142833

Submission

Device name
INTRAGen
Applicant
Jeisys Medical, Inc.
Seoul, KR
Received
September 30, 2014
Decision date
June 4, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OUH – Skin Resurfacing Rf Applicator
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Specialty
General, Plastic Surgery

Skin resurfacing

Other 510(k)s with product code OUH

510(k)DeviceApplicantDecision
K150409VIVACE Electrosurgical SystemOUH · Traditional Sung Hwan E&B Co.,Ltd01/15/2016SE
K130501IntensifOUH · Traditional Endymed Medical, Ltd.03/13/2014SE
K120513Glow by EndymedOUH · Traditional Endymed Medical, Ltd.05/08/2012SE
K101510Fractional Skin Resurfacing (FSR) ApplicatorOUH · Traditional Endymed Medical, Ltd.02/17/2011SE

More from Endymed Medical, Ltd.

510(k)DeviceDecision
K254185Potenza PrimeGEI · Traditional 09/11/2026SE
K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)GEX · Traditional 10/03/2025SE
K250065DENSITY; DENZA; DENSITY NoirGEI · Traditional 07/08/2025SE
K231216PotenzaGEI · Traditional 12/10/2024SE
K231287PotenzaGEI · Traditional 11/05/2024SE
K230663DensityGEI · Traditional 08/14/2023SE
K223685SmoothCool HR SystemGEX · Special 01/04/2023SE
K213484SmoothCool HR SystemGEX · Special 04/20/2022SE
K201685PotenzaGEI · Traditional 01/19/2021SE
K192545PotenzaGEI · Traditional 02/20/2020SE

Questions and answers

When was INTRAGen cleared by the FDA?

INTRAGen (K142833) received a 510(k) decision of Substantially Equivalent on June 4, 2015, 247 days after the submission was received.

What is the product code of K142833?

The FDA product code is OUH – Skin Resurfacing Rf Applicator, a Class II (moderate risk) device regulated under 21 CFR 878.4400.