JEISYS MEDICAL NORTH AMERICA INC

FDA Device Registration & Listing · Burlington, MA, US · Registration 3033715699

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033715699
FEI Number
3033715699
Entity Name
JEISYS MEDICAL NORTH AMERICA INC
City/State/Country
Burlington, MA, US
Establishment Address
70 Blanchard Rd Ste 303, Burlington, MA 01803, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
JEISYS MEDICAL NORTH AMERICA INC (Owner Number: 10091463)
Owner / Operator Contact Address
70 Blanchard Road, Suite 303, Burlington, MA 01803, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K231216
PMA Number
N/A

All Registered Proprietary Names

Potenza SmoothCool TRI-BEAM PRO, TRI-BEAM DENSITY; DENSITY Noir; DENZA SmoothCool HR system Intracel Pro Potenza

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUH Skin Resurfacing Rf Applicator General, Plastic Surgery Class 2 878.4400 2025-07-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-09
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2025-07-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-07-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-01-02

Official Correspondent

Sarah Dunne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JEISYS MEDICAL NORTH AMERICA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033715699. Last updated year: 2026. Please use registration number 3033715699 when referencing this establishment in official correspondence.
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