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510(k) K191929

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens by Unicon Optical Co., Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2019
Date Received
July 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Unicon Optical Co., Ltd.

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  • K213216 — Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (January 18, 2022)
  • K182734 — Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Dispo (May 16, 2019)
  • K141917 — UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY W (October 17, 2014)

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