Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6320](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6320) → KZF — Device, Medical Examination, Ac Powered # KZF · Device, Medical Examination, Ac Powered _General Hospital · 21 CFR 880.6320 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF ## Overview - **Product Code:** KZF - **Device Name:** Device, Medical Examination, Ac Powered - **Regulation:** [21 CFR 880.6320](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6320) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K954943](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K954943.md) | NEVOSCOPE | Nizar A. Mullani | Mar 27, 1996 | SESE | | [K952835](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K952835.md) | WELCH ALLYN VIDEO EPISCOPE | Welch Allyn, Inc. | Sep 22, 1995 | SESE | | [K945507](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K945507.md) | H 5100, H 5200, H 5300 | Rudolf Riester GmbH & Co. KG | Dec 9, 1994 | SESE | | [K941869](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K941869.md) | SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG | The Lighthouse For the Blind, Inc. | Aug 3, 1994 | SESE | | [K936088](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K936088.md) | WAVE FLUORESCENT MAGNIFIER | Burton Medical Products Corp. | Apr 26, 1994 | SESE | | [K940284](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K940284.md) | MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION | Meddev International Corp. | Feb 28, 1994 | SESE | | [K933564](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K933564.md) | SKYTRON EXAM LIGHT | Skytron, Div. the Kmw Group, Inc. | Feb 10, 1994 | SESE | | [K935832](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K935832.md) | CHROMOPHARE | Berchtold Holding GmbH | Feb 3, 1994 | SESE | | [K934259](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K934259.md) | AC-POWERED MEDICAL EXAMINATION LIGHT | Welch Allyn, Inc. | Jan 28, 1994 | SESE | | [K932719](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K932719.md) | RITTER MODEL 158 AND 159 EXAM LIGHTS | Midmark Corp. | Dec 2, 1993 | SESE | | [K924447](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K924447.md) | VITAPEN | Vitajet Corp. | Sep 27, 1993 | SESE | | [K931197](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K931197.md) | MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT | Meddev International Corp. | Sep 23, 1993 | SESE | | [K931645](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K931645.md) | HALUX TASKLIGHT | Burton Medical Products Corp. | Aug 20, 1993 | SESE | | [K931646](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K931646.md) | MI-4 VARIABLE SPOT LIGHT | Medical Illumination, Inc. | Aug 19, 1993 | SESE | | [K931026](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K931026.md) | MI-5 DIAGNOSTIC LIGHT | Medical Illumination, Inc. | Aug 19, 1993 | SESE | | [K925710](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K925710.md) | M.E.D. LIGHT | Medical Illumination, Inc. | Jun 4, 1993 | SESE | | [K922282](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K922282.md) | ILLUMINATOR VIII ULTRA/SPOT | Medical Illumination, Inc. | Mar 4, 1993 | SESE | | [K922278](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K922278.md) | ILLUMINATOR III | Medical Illumination, Inc. | Mar 4, 1993 | SESE | | [K922281](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K922281.md) | ILLUMINATOR VII MINI/SPOT LIGHT | Medical Illumination, Inc. | Feb 5, 1993 | SESE | | [K922280](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K922280.md) | ILLUMINATOR VII MINI/LUM LIGHT | Medical Illumination, Inc. | Feb 5, 1993 | SESE | ## Top Applicants - Medical Illumination, Inc. — 8 clearances - Burton Medical Products Corp. — 7 clearances - Welch Allyn, Inc. — 6 clearances - Meddev International Corp. — 2 clearances - Abco Dealers, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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