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510(k) K924090

THE ENDO OPTIKS MICROPROBE by Endo Optics, Inc. — Product Code HQB

K924090 is an FDA 510(k) premarket notification submitted by Endo Optics, Inc. for the device "THE ENDO OPTIKS MICROPROBE". The FDA issued a decision of Substantially Equivalent on February 1, 1993. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Endo Optics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1993
Date Received
August 13, 1992
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 Endo Optics, Inc.

  • K923600 — ENDO OPTIKS VALUE PACK (March 23, 1993)

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)
  • 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)

FDA data resources