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510(k) Data Aggregation
K Number
K202915Device Name
IRIS Thermocoagulator and Digital Colposcope
Manufacturer
Liger Medical, LLC
Date Cleared
2021-04-23
(206 days)
Product Code
HGI, HEX, PTZ
Regulation Number
884.4120Why did this record match?
Applicant Name (Manufacturer) :
Liger Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.
Device Description
The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be used separately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations.
The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves.
The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.
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K Number
K152843Device Name
Liger Medical HTU-110
Manufacturer
LIGER MEDICAL, LLC
Date Cleared
2016-06-24
(269 days)
Product Code
HGI
Regulation Number
884.4120Why did this record match?
Applicant Name (Manufacturer) :
LIGER MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Liger Medical HTU-110 is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe.
Device Description
Not Found
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K Number
K133273Device Name
LIGER MEDICAL ESU-110
Manufacturer
LIGER MEDICAL, LLC
Date Cleared
2014-02-12
(111 days)
Product Code
GEI, HGI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LIGER MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Liger Medical ESU-110 is intended to deliver high frequency electrical current for surgical procedures that can be performed with monopolar cutting and/or coagulation of tissue. One intended use of the Liger Medical ESU-110 Electrosurgical Unit is Loop Electrosurgical Excision Procedure (LEEP).
Device Description
The Liger Medical ESU-110 combines a high-quality, class I type BF electrosurgical generator and a smoke evacuation system into a single, compact unit. This integrated system is designed to perform low-power excision procedures of short duration. The ESU-110 is designed to be portable, single-purpose, and is intended for non-hospital locations where A/C power may be unreliable or unavailable.
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