Omni-Guide Holdings, Inc.

FDA Device Registration & Listing · Billerica, MA, US · Registration 3005350457

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
3005350457
FEI Number
3005350457
Entity Name
Omni-Guide Holdings, Inc.
City/State/Country
Billerica, MA, US
Establishment Address
43 Manning Road, Billerica, MA 01821, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
OMNIGUIDE, INC. (Owner Number: 9070939)
Owner / Operator Contact Address
43 Manning Rd, Billerica, MA 01821, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

OPEN FMSEALER DOMAIN SURGICAL SYSTEM Gas Filter Unit GYN-HP-29 BeamPath OTO Handpiece Set GYN-HP-46 Lower Genital Procedure Tray FlexGuide Ultra Tray Elevate ENT Instrumentation Tray BeamPath CO2 Laser Fiber Surgical Handpiece BeamPath Robotic Fiber Conduit BeamPath Neuro Handpiece Set BeamPath Neuro Handpiece Straight Laparoscopic Procedure Tray BeamPath Neuro Handpiece Bayonet BeamPath OTO Handpiece ENT Handpiece Tray Elevate ENT Handpiece ENT Handpiece ENT Handpiece Set FlexGuide Ultra Robotic Fiber Conduit GYN-LAP-33B Lower Genital Handpiece Laparoscopic Handpiece FMWAND FERROMAGNETIC SURGICAL SYSTEM Electrosurgical cutting and coagulation device and accessories Intelliguide Laser System Fiber Enabled Laser System C-Las FELS-25A-LS FELS-25A Powered laser surgical instrument FMWAND HANDPIECE SE OmniGuide Laser System with FlexGuide Ultra Powered laser surgical instrument - RevoLix 200 Powered laser surgical instrument - RevoLix Duo OTO-M OTO-S Powered laser surgical instrument - RevoLix Laser OmniGuide PRIMA Surgical Laser Fibers OmniGuide RFID Surgical Laser FIbers Powered laser surgical instrument TRIO Handpiece

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-07-14
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2021-07-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-08-13
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-11-19
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2021-07-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-07-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2009-11-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-08-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-07-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-11-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-12-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-12-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-11-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-12-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-05-23
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-11-25
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-08-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-05-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-05-30

Official Correspondent

Carlos Acosta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OMNIGUIDE, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003168101 LISA LASER PRODUCTS GMBH KATLENBURG-LINDAU Lower Saxony, DE

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-0008-2013 Gynex Corporation 2
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
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 3005350457. Last updated year: 2026. Please use registration number 3005350457 when referencing this establishment in official correspondence.
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