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510(k) K103813

SOPRO 281 by Sopro — Product Code NTN

K103813 is an FDA 510(k) premarket notification submitted by Sopro for the device "SOPRO 281". The FDA issued a decision of Substantially Equivalent on March 22, 2011. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Sopro has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2011
Date Received
December 29, 2010
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 Sopro

  • K223470 — C50 (December 14, 2023)
  • K121685 — SOPROCARE (March 12, 2013)
  • K092329 — SOPIX 2 (July 20, 2010)
  • K092583 — SOPROLIFE (January 13, 2010)
  • K082796 — SOPRO 184 CAMERA (April 1, 2009)
  • K080122 — SOPRO 670 ARTHROSCOPIC PUMP (July 11, 2008)
  • K070783 — SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR (December 13, 2007)
  • K072912 — SOPRO 225 DUAL HALOGEN LIGHT SOURCE (November 16, 2007)
  • K070102 — SOPRO 162 CAMERA (February 20, 2007)
  • K031593 — SOPRO 61D (September 16, 2003)

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)
  • 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