POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200— 510(k) K091962

Name: FDA 510(k) clearance K091962
Creator: U.S. Food and Drug Administration
Published: 2009-09-30

Substantially Equivalent

Lumenis, 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.. Device class: 2.

Clearance details

Applicant: Lumenis, Inc.
Product code: Code ODF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-07-01
Decision date: 2009-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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