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510(k) K090601

FSC 2 by Schoelly Imaging, Inc. — Product Code NTN

K090601 is an FDA 510(k) premarket notification submitted by Schoelly Imaging, Inc. for the device "FSC 2". The FDA issued a decision of Substantially Equivalent on May 11, 2009. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Schoelly Imaging, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2009
Date Received
March 5, 2009
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 Schoelly Imaging, Inc.

  • K090800 — VS-100 ILLUMINATION AND IMAGING SYSTEM (May 18, 2009)
  • K083553 — NASO-LARYNGO-PHARYNGOSCOPE (January 16, 2009)
  • K060899 — FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE (March 2, 2007)
  • K053412 — FLEXISCOPE, MODELS 50MH AND 50 MHC (February 23, 2006)

Other clearances for product code NTN

  • K141164 — ARTEMIS LIGHT ENGINE (March 16, 2015)
  • K133311 — ENDOLED (July 30, 2014)
  • K130819 — CLL- V1 LIGHT SOURCE (June 19, 2013)
  • 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)

FDA data resources