← Product Code [KZF](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF) · K954943 # NEVOSCOPE (K954943) _Nizar A. Mullani · KZF · Mar 27, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K954943 ## Device Facts - **Applicant:** Nizar A. Mullani - **Product Code:** [KZF](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF.md) - **Decision Date:** Mar 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6320 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Nevoscope is a hand-held, skin examination microscope that is similar in concept to the Episcope (k920103) and the Dermatoscope devices approved by the FDA. It is a non invasive device that is designed to view skin lesions by either surface illumination or transillumination. ## Device Story Hand-held skin examination microscope; utilizes surface illumination via fiber-optic halogen light ring and transillumination for scattered light imaging; features built-in mirror assembly for simultaneous multi-angle/elevation viewing; variable focus zoom lens for magnification; CCD TV camera for image capture and digitization; computer-based database for image storage and patient archival; used by clinicians in clinical settings; provides visual lesion data to assist in dermatological assessment and monitoring; benefits include enhanced visualization of lesion morphology through multiple lighting and viewing modalities. ## Clinical Evidence Device tested in clinical research settings for three years on skin lesion patients; evidence supported by research papers and scientific presentations demonstrating surface illumination and transillumination imaging capabilities. ## Technological Characteristics Hand-held microscope; AC-powered halogen lamp; optical fiber bundle; built-in mirror assembly; variable focus zoom lens; CCD TV camera; computer-based image storage/database; non-invasive. ## Regulatory 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. ## Predicate Devices - Episcope ([K920103](/device/K920103.md)) - Dermatoscope ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Mullani 28 Nizar A. Mullani 719 Santa Maria Sugar Land, TX 77478 Tel: (713) 494-0340 Fax: (713) 494-0377 Contact Person: Nizar A. Mullani Date of Summary: October 22, 1995 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 The assigned 510(k) number is: 954943 Nevoscope is a hand-held, skin examination microscope that is similar in concept to the Episcope (k920103) and the Dermatoscope devices approved by the FDA. It is a non invasive device that is designed to view skin lesions by either surface illumination or transillumination. Light is directed onto the skin by a special light ring that is coupled to an AC powered halogen lamp by an optical fiber bundle. Built-in mirrors permit viewing a skin lesion from different elevations and angles simultaneously. A variable focus zoom lens controls the magnification of the lesion and a CCD TV camera is attached for image viewing and digitization. Skin lesion images can be stored in the computer for analysis and archiving. The Nevoscope can be operated with surface illumination of the skin in a manner similar to the Episcope and the Dermatoscope. The transillumination modality offers additional information by lighting the skin lesion from scattered light within the skin. The mirror assembly, which provides simultaneous views of the lesion from different angles and elevations, is also a feature of the Nevoscope not found in either the Episcope or the Dermatoscope. Image capture by a CCD camera and viewing of the image by a TV monitor is available as an option in the Dermatoscope while it is a standard feature in the Nevoscope. The Nevoscope comprises a computer database and patient archival storage as a standard feature. The Episcope has been in clinical use since 1992 and has demonstrated its ability to highlight skin lesion features with surface lighting and oil immersion techniques. The Nevoscope has been in clinical research setting for the last three years and has been tested in skin lesion patients. Research papers and scientific presentations have been made that demonstrate the surface illumination imaging with the Nevoscope and the additional information obtained by transillumination. The Nevoscope and the Episcope are substantially equivalent in their ability to perform surface illumination and {1} Mullani 29 magnification of the skin lesion. However, the Nevoscope has additional features such as transillumination and mirror views not found with either the Episcope or the Dermatoscope. Nizar A. Mullani 4 Mulle Oct 22, 1995 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K954943](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KZF/K954943) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com