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510(k) K040839

COMPLETE BLINK-N-CLEAN LENS DROPS by Advanced Medical Optics, Inc. — Product Code MRC

K040839 is an FDA 510(k) premarket notification submitted by Advanced Medical Optics, Inc. for the device "COMPLETE BLINK-N-CLEAN LENS DROPS". The FDA issued a decision of Substantially Equivalent on October 19, 2004. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Advanced Medical Optics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2004
Date Received
March 31, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type

Other clearances by Advanced Medical Optics, Inc.

  • K081681 — VITRECTOMY CUTTER AND ACCESSORIES (October 8, 2008)
  • K081545 — ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (October 2, 2008)
  • K060366 — THE AMO OPHTHALMIC SURGICAL SYSTEM (April 7, 2006)
  • K042562 — LENS PLUS REWETTING DROPS (July 29, 2005)
  • K050648 — SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (April 5, 2005)
  • K032030 — BLINK CL LUBRICANT EYE DROPS (September 25, 2003)
  • K030092 — COMPLETE BRAND MULTI-PURPOSE SOLUTION (April 4, 2003)

Other clearances for product code MRC

  • K251876 — cleadew GP hydra one (October 9, 2025)
  • K200416 — Boston One Step Liquid Enzymatic Cleaner (September 23, 2020)
  • K201069 — VibrantVue Scleral Saline (July 31, 2020)
  • K182984 — MaxiTears Contacts PF (July 24, 2019)
  • K181566 — Nutrifill (October 22, 2018)
  • K181627 — Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step (August 10, 2018)
  • K180319 — Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning (March 27, 2018)
  • K173089 — Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditionin (November 27, 2017)
  • K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (November 16, 2017)
  • K130805 — MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (July 3, 2013)

FDA data resources