Home / 510(k) Clearances / K113679

510(k) K113679

LUCEA LED SURGICAL LIGHT SYSTEM by Maquet S.A.S. — Product Code NTN

K113679 is an FDA 510(k) premarket notification submitted by Maquet S.A.S. for the device "LUCEA LED SURGICAL LIGHT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 2012. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Maquet S.A.S. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2012
Date Received
December 14, 2011
Clearance Type
Special
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 Maquet S.A.S.

  • K214120 — GSS610N21 Series Steam Sterilizer (May 18, 2022)
  • K201927 — Getinge GSS610N Series Steam Sterilizer (March 1, 2021)
  • K172159 — Getinge GSS67N Series Steam Sterilizer (January 30, 2018)
  • K130513 — VOLISTA 400; VOLISTA 600 (May 8, 2013)
  • K070442 — POWERLED SURGICAL LIGHT SYSTEM (March 16, 2007)
  • K030071 — SERVO GUARD, MODEL 64 81 290 EH88E (April 26, 2004)

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)
  • 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