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510(k) K964005

SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE by Synergetics, Inc. — Product Code MPA

K964005 is an FDA 510(k) premarket notification submitted by Synergetics, Inc. for the device "SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE". The FDA issued a decision of Substantially Equivalent on June 9, 1997. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Synergetics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1997
Date Received
September 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

Other clearances by Synergetics, Inc.

  • K160103 — Spetzler Malis Dual Illuminating Bipolar Forceps (October 12, 2016)
  • K143123 — Synergetics PHOTON EX (February 24, 2015)
  • K121426 — AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS (July 10, 2012)
  • K121675 — VERSAVIT (June 21, 2012)
  • K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (April 23, 2012)
  • K110924 — DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS (December 7, 2011)
  • K091441 — SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET (October 30, 2009)
  • K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 (December 20, 2007)
  • K063489 — STRYKER INTRADISCAL RF GENERATOR (May 23, 2007)
  • K032598 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (November 24, 2003)

Other clearances for product code MPA

  • K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 (December 4, 2024)
  • K233653 — Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00) (August 5, 2024)
  • K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (March 30, 2023)
  • K202670 — Nam illumination probe with chopper (August 20, 2021)
  • K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator (September 11, 2015)
  • K143123 — Synergetics PHOTON EX (February 24, 2015)
  • K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (July 18, 2008)
  • K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (October 13, 2006)
  • K062259 — ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 (August 15, 2006)
  • K041108 — ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (June 22, 2004)

FDA data resources