Identifiers
- 510(k) Number
- K143119 FDA 510(k)
- FDA Product Code
- HEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1630 FDA 510(k)
- Regulation Number
- 884.1630 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LT-300 Video Colposcope is a diagnostic device classified as a colposcope and colpomicroscope, designed for visual examination of the cervix and vaginal walls. It provides magnified, high-resolution imaging to assist in identifying abnormalities such as dysplasia, lesions, or other pathological changes in gynecological assessments. The device incorporates video technology to capture and display real-time visuals, enhancing clinical evaluation accuracy during obstetrics and gynecology procedures.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as obstetrics and gynecology offices or hospitals. It is not sterile upon delivery and must be cleaned and maintained according to manufacturer guidelines before each use. The LT-300 Video Colposcope is FDA-cleared under a 510(k) submission (K143119) and falls under device class II regulation (884.1630). It is designed for continuous LED lighting and includes features such as adjustable magnification and progressive filters for optimal imaging conditions.
Frequently asked questions
What is the LT-300 Video Colposcope used for in clinical settings?
The LT-300 Video Colposcope is designed for visual examination of the cervix and vaginal walls during gynecological assessments. Its high-resolution video technology and adjustable magnification help clinicians identify abnormalities such as dysplasia or lesions, improving diagnostic accuracy in obstetrics and gynecology procedures.
Is the LT-300 Video Colposcope supplied sterile, and how should it be prepared for use?
The LT-300 Video Colposcope is not sterile upon delivery. It is a reusable medical instrument, so it must be thoroughly cleaned and maintained according to the manufacturer’s guidelines before each use to ensure proper hygiene and functionality.
Does the LT-300 Video Colposcope include any special imaging features?
Yes, the LT-300 Video Colposcope features continuous LED lighting for consistent illumination and includes progressive filters to optimize imaging conditions. Adjustable magnification further enhances the ability to examine cervical and vaginal tissues in detail.
What regulatory pathway does the LT-300 Video Colposcope follow, and what class does it belong to?
The LT-300 Video Colposcope was cleared through the FDA’s 510(k) process (K143119) and is classified as a Class II medical device under regulation number 884.1630. This classification reflects its role in diagnostic imaging for gynecological assessments.
Are there different models or sizes available for the LT-300 Video Colposcope?
The provided data does not specify multiple models or sizes for the LT-300 Video Colposcope. It is a single device designed for general use in obstetrics and gynecology settings, with features tailored to standard clinical needs.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LT-300HD Digital Colposcope - Lutech Medical, The Lutech 300-Series Colposcope Features - Lutech Medical, LUTECH LT-300 HD OPERATOR'S MANUAL Pdf Download, Lutech LT-300HD Digtal Colposcope (High Definition) - Florea Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143119 | Class II | Active |
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Manufacturer
- Manufacturer
- Lutech Industries
- FDA Applicant
- Lutech Industries, Inc.
Sources (1)
- FDA 510(k) K143119 24 fields · synced Oct 1, 2026