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510(k) K013204

AQUIFY LENS COMFORT DROPS by Ciba Vision Corporation — Product Code MRC

K013204 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "AQUIFY LENS COMFORT DROPS". The FDA issued a decision of Substantially Equivalent on April 3, 2002. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2002
Date Received
September 25, 2001
Clearance Type
Traditional
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 Ciba Vision Corporation

  • K133176 — AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL (January 29, 2014)
  • K123994 — DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PL (February 21, 2013)
  • K113168 — DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTA (March 30, 2012)
  • K083216 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (April 14, 2009)
  • K073459 — CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES (February 28, 2008)
  • K072777 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (January 24, 2008)
  • K062262 — CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIG (November 14, 2006)
  • K041820 — SOLO-CARE AQUA ANTIMICROBIAL LENS CASE (September 9, 2005)
  • K050250 — AQUIFY MULTIPURPOSE SOLUTION (August 10, 2005)
  • K050065 — FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES (May 27, 2005)

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