Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)

Q: What is the product code of K253918?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.

FDA 510(k) K253918 · F Care Systems USA, LLC

Substantially Equivalent

510(k) numberK253918

Submission

Device name: Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
Applicant: F Care Systems USA, LLC
Miami, FL, US
Received: December 8, 2025
Decision date: June 2, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEI – Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4400
Specialty: General, Plastic Surgery

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K253859	Scarlet Pro (Scarlet Pro)GEI · Traditional	VIOL Co., Ltd.	08/27/2026SE
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K261179	AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional	Gimmi GmbH	07/22/2026SE
K253504	VolnewmerGEI · Traditional	Classys, Inc.	07/13/2026SE
K254056	THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional	Olympus Medical Systems Corp.	07/01/2026SE
K253484	Lutronic GeniusGEI · Traditional	Cynosure Lutronic Technology Corporation	06/29/2026SE
K251492	Irrigation Tubing Bipolar Cord SetGEI · Traditional	New Deantronics Taiwan , Ltd.	06/29/2026SE
K260636	Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional	Stryker Sustainability Solutions	06/18/2026SE

510(k)	Device	Decision
K252704	F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)GEI · Traditional	11/24/2025SE
K220725	HPR45iGEI · Traditional	03/20/2023SE
K210077	Med RF 4000ONQ · Traditional	12/17/2021SE

Questions and answers

When was Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) cleared by the FDA?

Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (K253918) received a 510(k) decision of Substantially Equivalent on June 2, 2026, 176 days after the submission was received.

What is the product code of K253918?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.