OPTOVISION Endoscopic Light Source Unit
FDA 510(k) K243591 · Optosurgical, LLC
510(k) numberK243591
Submission
- Device name
- OPTOVISION Endoscopic Light Source Unit
- Applicant
- Optosurgical, LLC
Columbia, MD, US - Received
- November 20, 2024
- Decision date
- February 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
Other 510(k)s with product code OWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254180 | PerfusiX-ImagingOWN · Traditional | LIMIS Development B.V. | 07/24/2026SE |
| K242163 | SmartSurgN Visualization SystemOWN · Traditional | SmartsurgN, Inc. | 04/20/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | Karl Storz SE & CO. KG | 02/26/2026SE |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)OWN · Traditional | VPIX Medical, Inc. | 02/13/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | Stryker Endoscopy | 02/12/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | Karl Storz SE & CO. KG | 02/12/2026SE |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…OWN · Traditional | Olympus Medical Systems Corp. | 11/12/2025SE |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…OWN · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 07/24/2025SE |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3)OWN · Traditional | Samantree Medical SA | 08/19/2024SE |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitOWN · Traditional | Karl Storz SE & CO. KG | 11/21/2023SE |
Questions and answers
When was OPTOVISION Endoscopic Light Source Unit cleared by the FDA?
OPTOVISION Endoscopic Light Source Unit (K243591) received a 510(k) decision of Substantially Equivalent on February 19, 2025, 91 days after the submission was received.
What is the product code of K243591?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.