ZIMMER MEDIZINSYSTEME GMBH

FDA Device Registration & Listing · NEU-ULM Bavaria, DE · Registration 8010720

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
8010720
FEI Number
7759
Entity Name
ZIMMER MEDIZINSYSTEME GMBH
City/State/Country
NEU-ULM Bavaria, DE
Establishment Address
JUNKERSSTRASSE 9, NEU-ULM Bavaria 89231, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ZIMMER MEDIZINSYSTEME GMBH (Owner Number: 8010720)
Owner / Operator Contact Address
3 Goodyear Suite B, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ThermoPro ThermoTK Tecarpuls II Cynosure SmartCool Family Cold Air Device: SmartCool, SmartCool 6, Cryo C ZShape clTrac Zimmer Trodes CryoOne CRYO 6 Z STIM CoolTone CoolTone ZWave Pro enPuls Pro ZWaveQ enPuls2 enShock Endopuls FSWT EndoPuls 811 ZWave US-Wave

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5290 2016-11-30
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2025-02-18
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2023-05-31
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-12-20
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2024-07-17
ITH Equipment, Traction, Powered Physical Medicine Class 2 890.5900 2023-05-31
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-11-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2007-08-23
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2024-07-26
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2019-11-20
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2022-04-06
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 1984-12-13

Official Correspondent

Valeria Perez Zimmer

US Agent Details

Valeria Perez Zimmer Business: ZIMMER MEDIZINSYSTEMS CORP. Email: v.zimmer@zimmerusa.com Phone: (800) 3273576

Related Public Records

Same Entity

ZIMMER MEDIZINSYSTEME GMBH
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
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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 8010720. Last updated year: 2026. Please use registration number 8010720 when referencing this establishment in official correspondence.
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