Hemolaser Hemoscope
510(k) K893816
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893816 | Date1 Feb 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LYK
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hemolaser Hemoscope is a flexible endoscope classified under the Angioscope category (FDA product code LYK), designed for visualizing internal blood vessels and vascular structures. It combines laser illumination with endoscopic imaging to provide real-time visualization of vascular anatomy, aiding in diagnostic and therapeutic procedures within gastroenterology and urology.
This device is supplied as a reusable medical instrument and is intended for use in controlled clinical settings such as operating rooms or endoscopy suites. It is regulated under FDA 510(k) clearance (K893816) and falls under Class II device classification (FDA regulation 876.1500). The Hemolaser Hemoscope is approved for use in both gastroenterology and urology, with advisory committee oversight from the Gastroenterology and Urology panels.
Questions
AI-generated answers, 1 Oct 2026
What is the Hemolaser Hemoscope used for in clinical practice?
The Hemolaser Hemoscope is designed for visualizing internal blood vessels and vascular structures during procedures in gastroenterology and urology. Its laser-assisted imaging provides real-time clarity of vascular anatomy, aiding both diagnostic assessments and therapeutic interventions, such as identifying abnormalities or guiding interventions within the vascular system.
Is the Hemolaser Hemoscope a single-use or reusable device?
The Hemolaser Hemoscope is supplied as a reusable medical instrument, intended for use in controlled clinical settings like operating rooms or endoscopy suites. Reusability requires adherence to strict cleaning, sterilization, and maintenance protocols to ensure patient safety and device performance across multiple procedures.
What regulatory pathway does the Hemolaser Hemoscope follow?
The Hemolaser Hemoscope has obtained FDA 510(k) clearance under the traditional review pathway, classified as a Class II device (FDA regulation 876.1500). This clearance was granted in 1990 following a determination of substantial equivalence to a predicate device, with advisory oversight from the Gastroenterology and Urology panels.
Which medical specialties primarily use the Hemolaser Hemoscope?
The Hemolaser Hemoscope is approved for use in gastroenterology and urology. Its capabilities are particularly valuable in these specialties for procedures requiring detailed visualization of vascular structures, such as endoscopic evaluations or interventions within the gastrointestinal or urinary tracts.
How is the device’s sterility maintained for reuse?
As a reusable device, the Hemolaser Hemoscope must undergo thorough cleaning, disinfection, and sterilization between uses to prevent cross-contamination. Manufacturers and clinical staff must follow validated protocols, such as autoclaving or chemical sterilization, to ensure the device remains safe and functional for repeated clinical applications.