Home / 510(k) Clearances / K000420

510(k) K000420

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 by Retinalabs.Com — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2000
Date Received
February 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Ophthalmic
Device Class
Class II
Regulation Number
880.5725
Review Panel
OP
Submission Type

Other clearances by Retinalabs.Com

  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K000418 — PDT DOSECALCULATOR, MODEL 80000 (October 24, 2000)
  • K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAM (May 9, 2000)
  • K000416 — TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 (May 8, 2000)

Other clearances for product code MRH

  • K243503 — VIA360™ Surgical System (February 14, 2025)
  • K232214 — OMNI Surgical System (August 25, 2023)
  • K213173 — TrabEx Pro (June 8, 2022)
  • K212797 — iPrime Viscodelivery System (January 6, 2022)
  • K211680 — Streamline Surgical System (October 8, 2021)
  • K202678 — OMNI Surgical System (March 1, 2021)
  • K201953 — OMNI PLUS Surgical System (August 11, 2020)
  • K173332 — OMNI Surgical System (December 21, 2017)
  • K171905 — VISCO 360 Viscosurgical System (July 27, 2017)
  • K143205 — Viscoelastic Injector (December 5, 2014)