Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4580](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4580) → PSN — Light Based Imaging

# PSN · Light Based Imaging

_General, Plastic Surgery · 21 CFR 878.4580 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN

## Overview

- **Product Code:** PSN
- **Device Name:** Light Based Imaging
- **Regulation:** [21 CFR 878.4580](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4580)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **3rd-party reviewable:** yes

## Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

## Classification Rationale

Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K230448](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K230448.md) | DeepX DermoSight Dermatoscope | Deepx Health, LLC | May 17, 2023 | SESE |
| [K213957](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K213957.md) | Demetra Dermatoscope BDEM-01 | Barco N.V. | Mar 11, 2022 | SESE |
| [K201408](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K201408.md) | Demetra Analytics Toolkit | Barco N.V. | Feb 18, 2021 | SESE |
| [K192829](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K192829.md) | Demetra BDEM-01 Dermatoscope | Barco N.V. | Dec 13, 2019 | SESE |
| [K180162](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K180162.md) | VivaScope System | Caliber Imaging & Diagnostics, Inc. | May 3, 2018 | SESE |
| [K080788](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K080788.md) | VIVASCOPE SYSTEM, MODEL 1500, 3000 | Lucid, Inc. | Sep 17, 2008 | SESE |
| [K062736](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K062736.md) | SIASCOPE V | Astron Clinica Limited | Sep 14, 2007 | SESE |
| [K040171](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K040171.md) | MICRODERM, MODEL/VERSION 3.5 | Visiomed AG | Jun 8, 2004 | SESE |
| [K023729](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K023729.md) | SIASCOPE II | Astron Clinica Limited | Feb 3, 2003 | SESE |
| [K011273](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN/K011273.md) | SI ASCOPE | Astron Clinica Limited | Feb 20, 2002 | SESE |

## Top Applicants

- Astron Clinica Limited — 3 clearances
- Barco N.V. — 3 clearances
- Caliber Imaging & Diagnostics, Inc. — 1 clearance
- Deepx Health, LLC — 1 clearance
- Lucid, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PSN)

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