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510(k) K070442

POWERLED SURGICAL LIGHT SYSTEM by Maquet S.A. — Product Code FSY

K070442 is an FDA 510(k) premarket notification submitted by Maquet S.A. for the device "POWERLED SURGICAL LIGHT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 2007. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Maquet S.A. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2007
Date Received
February 15, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Maquet S.A.

  • 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)
  • K113679 — LUCEA LED SURGICAL LIGHT SYSTEM (January 12, 2012)
  • K030071 — SERVO GUARD, MODEL 64 81 290 EH88E (April 26, 2004)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources