Home / 510(k) Clearances / K130819

510(k) K130819

CLL- V1 LIGHT SOURCE by Olympus Winter & Ibe GmbH — Product Code NTN

K130819 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "CLL- V1 LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on June 19, 2013. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2013
Date Received
March 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Led Light Source
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals

Other clearances by Olympus Winter & Ibe GmbH

  • K260649 — OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 1 (May 21, 2026)
  • K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep p (September 23, 2025)
  • K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessor (August 18, 2023)
  • K221522 — HF-cables (resusable) (January 19, 2023)
  • K223183 — Light-Guide Cables (January 13, 2023)
  • K213207 — Sheath, Stopcock Accessory (December 22, 2021)
  • K203492 — Instrument tray, for semi-rigid ureteroscope (September 15, 2021)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K203682 — Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer an (May 17, 2021)
  • K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (April 28, 2021)

Other clearances for product code NTN

  • K141164 — ARTEMIS LIGHT ENGINE (March 16, 2015)
  • K133311 — ENDOLED (July 30, 2014)
  • K122831 — VIDEO SYSTEM CENTER (December 14, 2012)
  • K113679 — LUCEA LED SURGICAL LIGHT SYSTEM (January 12, 2012)
  • K103813 — SOPRO 281 (March 22, 2011)
  • K102167 — LO-50 LED LIGHT SOURCE (August 17, 2010)
  • K091829 — PLS PORTABLE LIGHT SOURCE (July 28, 2009)
  • K090601 — FSC 2 (May 11, 2009)

FDA data resources