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510(k) K143351

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

K143351 is an FDA 510(k) premarket notification submitted by Novabay Pharmaceuticals, Inc. for the device "iCase Contact Lens Case". The FDA issued a decision of Substantially Equivalent on April 29, 2015. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Novabay Pharmaceuticals, Inc. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code LRX

  • K252175 — LANDR Contact LENS Case (February 10, 2026)
  • K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F) (August 1, 2025)
  • K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (October 9, 2024)
  • 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)

FDA data resources