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510(k) K163632

Katalyst Cyclophotocoagulation Probe by Katalyst Surgical, LLC — Product Code LQJ

K163632 is an FDA 510(k) premarket notification submitted by Katalyst Surgical, LLC for the device "Katalyst Cyclophotocoagulation Probe". The FDA issued a decision of Substantially Equivalent on June 15, 2017. The device falls under product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser), a Class II device regulated under 21 CFR 886.4390. Katalyst Surgical, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2017
Date Received
December 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

Other clearances by Katalyst Surgical, LLC

  • K213610 — Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, K (October 7, 2022)
  • K192963 — Kogent Torus Ultrasonic Aspirator (June 19, 2020)
  • K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES (April 9, 2015)
  • K140362 — KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATA (September 15, 2014)
  • K123172 — KOGENT BIPOLAR FORCEPS (December 21, 2012)
  • K121187 — KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES (September 17, 2012)

Other clearances for product code LQJ

  • K931356 — SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR (September 7, 1993)
  • K921414 — TROKEL /3 GONIO LASER LENS (November 16, 1992)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)
  • K893731 — SHIELDS T.C. LASER LENS (August 17, 1989)
  • K884694 — MQL 20 ND:YAG OPHTHALMIC LASER (November 30, 1988)
  • K883719 — INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (October 18, 1988)
  • K883270 — IRIS ND:YAG OPTHALMIC LASER (October 13, 1988)
  • K882574 — BOLDREY PERIPHERAL RETINAL LENS (July 29, 1988)
  • K872802 — TROKEL SINGLE MIRROR YAG LASER LENS (September 4, 1987)
  • K871245 — LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 (May 7, 1987)

FDA data resources