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510(k) K031957

MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION by Ciba Vision Corporation — Product Code LPN

K031957 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION". The FDA issued a decision of Substantially Equivalent on August 14, 2003. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2003
Date Received
June 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
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 LPN

  • K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (December 6, 2022)
  • K221263 — Aqua Naina Plus Sterile Saline Solution (October 12, 2022)
  • K202932 — ABT12 multi-purpose solution (May 28, 2021)
  • K210051 — OTE MPS 045 Multi-purpose Lens Care Solution (May 26, 2021)
  • K193441 — Aqua Naina Sterile Saline Solution (May 26, 2020)
  • K200747 — PuriLens Plus Preservative Free Saline (May 15, 2020)
  • K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (March 2, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K191795 — AOCup Lens Case with AODisc (July 31, 2019)
  • K170483 — Bausch + Lomb Sensitive Eyes Plus Saline Solution (April 11, 2017)

FDA data resources