Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1630](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1630) → HEX — Colposcope (And Colpomicroscope) # HEX · Colposcope (And Colpomicroscope) _Obstetrics/Gynecology · 21 CFR 884.1630 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX ## Overview - **Product Code:** HEX - **Device Name:** Colposcope (And Colpomicroscope) - **Regulation:** [21 CFR 884.1630](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1630) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## Identification A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts. ## Classification Rationale Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. ## Recent Cleared Devices (20 of 56) Showing 20 most recent of 56 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233043](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K233043.md) | Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. | Jun 14, 2024 | SESE | | [K190187](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K190187.md) | Gynescope System | Illumigyn , Ltd. | May 8, 2019 | SESE | | [K182764](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K182764.md) | Biop Digital Colposcope | Biop Medical , Ltd. | Nov 27, 2018 | SESE | | [K181034](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K181034.md) | Pocket Colposcope System | Hadleigh Health Technologies, LLC | Sep 21, 2018 | SESE | | [K170446](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K170446.md) | LT-300 SD Digital Video Colposcope | Lutech Industries, Inc. | May 21, 2017 | SESE | | [K161871](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K161871.md) | EVA (Enhanced Visual Assessment) System | Mobileodt , Ltd. | Dec 19, 2016 | SESE | | [K160341](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K160341.md) | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | Sep 14, 2016 | SESE | | [K160380](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K160380.md) | LT-300 HD | Lutech Industries, Inc. | May 13, 2016 | SESE | | [K151878](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K151878.md) | Video Colposcope | Edan Instruments, Inc. | Dec 1, 2015 | SESE | | [K143119](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K143119.md) | LT-300 Video Colposcope | Lutech Industries, Inc. | Dec 18, 2014 | SESE | | [K140754](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K140754.md) | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | CooperSurgical, Inc. | Oct 23, 2014 | SESE | | [K132423](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K132423.md) | THE GYNOCULAR | Gynius AB | Apr 8, 2014 | SESE | | [K122311](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K122311.md) | GC-3000E DIGITAL COLPOSCOPE | Shenzhen Goldcare Meditech Co., Ltd. | Sep 18, 2013 | SESE | | [K122973](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K122973.md) | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | Medgyn Products, Inc. | Jun 12, 2013 | SESE | | [K110147](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K110147.md) | ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE | Sti Medical Systems, LLC | Apr 8, 2011 | SESE | | [K092433](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K092433.md) | DYSIS | Forth Photonics Hellas SA | Mar 10, 2011 | SESE | | [K090324](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K090324.md) | ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY | Sti Medical Systems | Dec 20, 2010 | SESE | | [K101141](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K101141.md) | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 | Seiler Precision Microscopes | Aug 6, 2010 | SESE | | [K100595](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K100595.md) | ECLERIS MICROSTAR COLPOSCOPE | Ecleris USA | Jul 9, 2010 | SESE | | [K072691](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K072691.md) | CERVICAL MD, MODEL C10 | Sti Medical Systems | Jan 31, 2008 | SESE | ## Top Applicants - Wallach Surgical Devices, Inc. — 4 clearances - Dynatech Cryomedical Co. — 3 clearances - Lutech Industries, Inc. — 3 clearances - CooperSurgical, Inc. — 2 clearances - Hill-Med, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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