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510(k) K162869

Contact Lens Case by Ningbo Yinzhou Zonghai Artware Co., Ltd. — Product Code LRX

K162869 is an FDA 510(k) premarket notification submitted by Ningbo Yinzhou Zonghai Artware Co., Ltd. for the device "Contact Lens Case". The FDA issued a decision of Substantially Equivalent on December 9, 2016. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2016
Date Received
October 13, 2016
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

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  • 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)
  • K160005 — Contact Lens Case (multiple brand name) (June 7, 2016)

FDA data resources