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510(k) K143351

iCase Contact Lens Case by Novabay Pharmaceuticals, Inc. — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2015
Date Received
November 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Novabay Pharmaceuticals, Inc.

  • K131542 — NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC (July 24, 2013)
  • K113820 — NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER (August 8, 2012)
  • K081009 — NEUTROPHASE (May 20, 2008)
  • K071056 — NEUTROPHASE WOUND CLEANSER (September 28, 2007)

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  • K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Cas (August 30, 2023)
  • K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (December 4, 2017)
  • K172925 — Contact Lens Case, Model: A-1, B-1 (November 30, 2017)
  • K173365 — Bausch + Lomb Boston Scleral Lens Case (November 17, 2017)
  • K171539 — Contact Lens Case (July 14, 2017)
  • K171163 — Contact Lens Case Round Glasses (June 27, 2017)
  • K162869 — Contact Lens Case (December 9, 2016)