MacroLux Medical Technology Co., Ltd. · Class II · Cleared Apr 8, 2026
| K-number | K260420 |
| Device name | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) |
| Applicant | MacroLux Medical Technology Co., Ltd. |
| Product code | EOQ |
| Device class | Class II |
| Decision date | Apr 8, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 874.4680 |
The LoopView® Single-Use Digital Flexible Bronchoscope is a sterile, single-use endoscope designed for examination and procedures within the airways and tracheobronchial tree in adults. It provides visualization via a reusable MACROLUX™ video processor and is intended for use in hospital environments. The system includes a flexible bronchoscope with a maneuverable tip, camera, LED light source, and a video processor for displaying live imaging.
The subject device and predicate device share the same indications for use, population, anatomic site, prescription status, performance, direction of view, digital video technology, illumination source, sterilization method, biocompatibility, and electrical performance. The subject device differs in field of view, depth of view, working length, maximum insertion portion width, minimum working channel width, and deflection angle specifications.
ISO 11135 (sterilization validation), ISO 10993-1, 5, 10, 11, and 23 (biocompatibility), IEC 60601-1-2, IEC 60601-2-18 (electromagnetic compatibility and electrical safety), IEC 62471 (photobiological safety), and mechanical testing including tensile stress, fatigue, insertion/extraction cycles, and bending reliability.
View the full FDA submission: accessdata.fda.gov