Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart B — Diagnostic Devices](/submissions/SU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 878.1820](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1820) → OYD — Optical Diagnostic Device For Melanoma Detection

# OYD · Optical Diagnostic Device For Melanoma Detection

_General, Plastic Surgery · 21 CFR 878.1820 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/OYD

## Overview

- **Product Code:** OYD
- **Device Name:** Optical Diagnostic Device For Melanoma Detection
- **Regulation:** [21 CFR 878.1820](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1820)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma. Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P090012](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/OYD/P090012.md) | MELAFIND | Strata Skin Sciences, Inc. | Nov 1, 2011 | APPR |

## Top Applicants

- Strata Skin Sciences, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/OYD](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/OYD)

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