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510(k) K113857

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE by Synergetics, Inc. — Product Code HQB

K113857 is an FDA 510(k) premarket notification submitted by Synergetics, Inc. for the device "SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE". The FDA issued a decision of Substantially Equivalent on April 23, 2012. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Synergetics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2012
Date Received
December 30, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
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)
  • 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)
  • K020220 — ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE (August 23, 2002)

Other clearances for product code HQB

  • K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex S (November 3, 2022)
  • K191846 — MAXReach Laser Probe (December 23, 2019)
  • K182646 — Vitreq disposable laser probes, light fibers and Chandelier (May 1, 2019)
  • K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE (November 14, 2013)
  • K122997 — 23GA CURVED ILLUMINATING LASER PROBE (June 26, 2013)
  • K122905 — PEREGRINE 23GA CURVED LASER PROBE (April 30, 2013)
  • K110951 — 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VAL (October 17, 2011)
  • K111493 — NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (July 27, 2011)
  • K110228 — NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (February 23, 2011)
  • K964380 — LC-250 INFRARED LIGHT COAGULATOR (January 22, 1997)

FDA data resources