PSN · Light Based Imaging
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | PSN |
|---|---|
| Device Name | Light Based Imaging |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | May 17, 2023 | SESE |
| K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | Mar 11, 2022 | SESE |
| K201408 | Demetra Analytics Toolkit | Barco N.V. | Feb 18, 2021 | SESE |
| K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | Dec 13, 2019 | SESE |
| K180162 | VivaScope System | Caliber Imaging & Diagnostics, Inc. | May 3, 2018 | SESE |
| K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | Lucid, Inc. | Sep 17, 2008 | SESE |
| K062736 | SIASCOPE V | Astron Clinica Limited | Sep 14, 2007 | SESE |
| K040171 | MICRODERM, MODEL/VERSION 3.5 | Visiomed AG | Jun 8, 2004 | SESE |
| K023729 | SIASCOPE II | Astron Clinica Limited | Feb 3, 2003 | SESE |
| K011273 | 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
