VIORA LTD.

FDA Device Registration & Listing · Migdal HaEmek Northern, IL · Registration 3005695724

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
3005695724
FEI Number
3005695724
Entity Name
VIORA LTD.
City/State/Country
Migdal HaEmek Northern, IL
Establishment Address
Sagi 2000, Industrial Park, Migdal HaEmek Northern 1812003, IL
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
VIORA LTD. (Owner Number: 9086237)
Owner / Operator Contact Address
Sinclair Pharmaceuticals Limited, Eden House, Lakeside, Chester Business Park, Chester, GB-CHW CH4 9QT, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201064
PMA Number
N/A

All Registered Proprietary Names

V20 System With V-FC_V-FC Pro , V30 System With V-FC_V-FC Pro, V10 System With V-FC_V-FC Pro V20 System V20 System with V-ST Handpiece, V-IPL Handpiece,V-FORM Handpiece with BC and FC Applicators Dermafuse Flat Single-Use Tip Brush Single-Use Tip V10 System and V20 System with V-FORM Handpiece with BC Small,Medium and Large Applicators V30 System with V-ST HP,V-IPL HP,V-Nd:YAG HP,V-FORM HP with BC Small,Medium, Large Applicators V30 V20 System With V-VR Handpiece , V30 System With V-VR Handpiece , V10 System With V-VR Handpiece V30 System With V-FR Handpiece, V20 System With V-FR Handpiece, V10 System With V-FR Handpiece

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-08-19
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2020-08-19
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2020-08-19
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2014-11-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-11-18
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2016-03-06
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2016-03-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-03-06
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2020-11-08
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2016-12-28
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2016-12-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-12-28
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2014-04-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-04-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-01-15
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2021-01-15
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2021-01-15
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2020-08-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-08-19
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2020-08-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-08-19

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

VIORA LTD.
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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005695724. Last updated year: 2026. Please use registration number 3005695724 when referencing this establishment in official correspondence.
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