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510(k) K220263

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers by Vortex Surgical, Inc. — Product Code HQB

K220263 is an FDA 510(k) premarket notification submitted by Vortex Surgical, Inc. for the device "Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers". The FDA issued a decision of Substantially Equivalent on November 3, 2022. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Vortex Surgical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2022
Date Received
January 31, 2022
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 Vortex Surgical, Inc.

  • K191846 — MAXReach Laser Probe (December 23, 2019)

Other clearances for product code HQB

  • 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)
  • K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (April 23, 2012)
  • 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