Home / 510(k) Clearances / K222395

510(k) K222395

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo by Ellex Medical Pty, Ltd. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2022
Date Received
August 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ellex Medical Pty, Ltd.

  • K212630 — Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo (December 16, 2021)
  • K190786 — Eye Prime (April 11, 2019)
  • K142398 — Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Int (July 14, 2015)
  • K122202 — ELLEX 2RT (July 1, 2013)
  • K081565 — INTEGRE PRO, MODEL L2RY (July 2, 2008)
  • K080423 — INTEGRE, MODEL LP581 (March 11, 2008)
  • K052777 — LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE (March 16, 2006)
  • K041598 — LASEREX, MODEL LP4532 (October 6, 2004)
  • K021550 — LUMENIS SELECTA DUET (August 9, 2002)
  • K003955 — LASEREX INTEGRE, MODEL LP2532 (March 15, 2001)

Other clearances for product code HQF

  • K251507 — INTEGRE LIO (February 6, 2026)
  • K251772 — Navilas Laser System 577sl (156691) (October 29, 2025)
  • K243014 — EyeQ nanoECP (June 18, 2025)
  • K240615 — Leos Laser and Endoscopy System (April 3, 2025)
  • K242397 — LYNX Photocoagulator (October 25, 2024)
  • K233911 — VISULAS combi (September 6, 2024)
  • K232417 — MR Q; MR Q SUPINE; MR Q SLT (January 25, 2024)
  • K230722 — Eagle device (December 8, 2023)
  • K232051 — VISULAS green (October 24, 2023)
  • K230350 — VISULAS yag (September 22, 2023)