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510(k) K191846

MAXReach Laser Probe by Vortex Surgical, Inc. — Product Code HQB

K191846 is an FDA 510(k) premarket notification submitted by Vortex Surgical, Inc. for the device "MAXReach Laser Probe". The FDA issued a decision of Substantially Equivalent on December 23, 2019. 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
December 23, 2019
Date Received
July 10, 2019
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.

  • K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex S (November 3, 2022)

Other clearances for product code HQB

  • K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex S (November 3, 2022)
  • 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