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510(k) K882441

SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION by Surgical Laser Technologies, Inc. — Product Code HQB

K882441 is an FDA 510(k) premarket notification submitted by Surgical Laser Technologies, Inc. for the device "SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION". The FDA issued a decision of Substantially Equivalent on September 26, 1988. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Surgical Laser Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1988
Date Received
June 14, 1988
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 Surgical Laser Technologies, Inc.

  • K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS (November 8, 2004)
  • K023624 — SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-676 (January 27, 2003)
  • K011409 — SLT LASERPRO CTH HOLMIUM LASER SYSTEM (June 14, 2001)
  • K010041 — SLT DIFFUSER FIBER (March 7, 2001)
  • K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MM (March 15, 1999)
  • K983050 — PNEUMATIC CUTTER SYSTEM (November 25, 1998)
  • K981041 — SLT BIPOLAR SHEATH (August 27, 1998)
  • K972548 — SLT CL MD CONTACT LASER SYSTEM (April 21, 1998)
  • K980156 — SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS (February 27, 1998)
  • K960821 — SLT FUMICH PROBE GUIDE (May 16, 1996)

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