ViOptix, Inc. · Class II · Cleared Jun 26, 2025
| K-number | K250519 |
| Device name | Lap.Ox Laparoscopic Tissue Oximeter |
| Applicant | ViOptix, Inc. |
| Product code | MUD |
| Device class | Class II |
| Decision date | Jun 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.2700 |
The Lap.Ox Laparoscopic Tissue Oximeter is a cordless, battery-powered device that measures oxygen saturation (StO2) in tissue during minimally invasive laparoscopic surgery. It consists of a reusable main unit with a display screen and a disposable kit containing sensors, a laparoscopic tube, and batteries. The device uses spectrophotometric oximetry with red and near-infrared light to estimate tissue oxygenation and is intended for adult patients undergoing circulatory or perfusion assessment during laparoscopy.
Both the proposed Lap.Ox and predicate Intra.Ox 2.0 are cordless, battery-powered, biocompatible tissue oximeters with identical physical architecture: a reusable main unit paired with a disposable kit and sheath. The key difference is application method—Lap.Ox uses a laparoscopic tube inserted through a surgical port, while Intra.Ox is handheld and non-invasive. The Lap.Ox uses three wavelengths (760nm, 810nm, 840nm) versus the predicate's five wavelengths (730nm, 760nm, 810nm, 845nm, 895nm), but both employ the same spectrophotometric oximetry principle.
ISO 13485:2016 (quality management), ISO 14971:2019 (risk management), IEC 62304:2006 (software life cycle), IEC 60601-1-2:2014 (electromagnetic compatibility), ISO 10993 series (biocompatibility), ISO 11135:2014 (ethylene oxide sterilization), AAMI TIR ST98:2022 (cleaning validation), ASTM F88/F88M-23 (seal strength), ASTM F1980-21 (accelerated aging), and ANSI/AAMI HE75:2009 (human factors engineering).
ViOptix demonstrated substantial equivalence by showing that the laparoscopic design modification and reduced wavelength set do not raise different safety or effectiveness questions. Comprehensive bench testing confirmed the three-wavelength configuration achieves comparable StO2 performance to the five-wavelength predicate. A clinical study on human subjects showed the Lap.Ox performs comparably to the predicate device. Since both devices share the same intended use (tissue oxygenation monitoring), same intended users (physicians/surgeons/nurses), same patient population (adults), and pass identical biocompatibility, sterilization, and electrical safety standards, the design differences are purely operational without introducing new risks.
View the full FDA submission: accessdata.fda.gov