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510(k) K131783

POLAROID CONTACTSPOD by Viopti, Ltd. — Product Code LRX

K131783 is an FDA 510(k) premarket notification submitted by Viopti, Ltd. for the device "POLAROID CONTACTSPOD". The FDA issued a decision of Substantially Equivalent on February 21, 2014. 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
February 21, 2014
Date Received
June 17, 2013
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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  • 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