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510(k) K130753

STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE by Watchdog Group, LC — Product Code LRX

K130753 is an FDA 510(k) premarket notification submitted by Watchdog Group, LC for the device "STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on June 13, 2013. 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
June 13, 2013
Date Received
March 19, 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)
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  • 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