POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200— 510(k) K091962
Substantially EquivalentLumenis, Inc.
FDA 510(k) clearance K091962 for POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200, Substantially Equivalent on 2009-09-30. Applicant: Lumenis, Inc..
Clearance details
- Applicant
- Lumenis, Inc.
- Product code
- Code ODF
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.