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510(k) K213216

Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens by Unicon Optical Co., Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2022
Date Received
September 29, 2021
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.

  • K241707 — OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ (July 12, 2024)
  • K191929 — UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (September 17, 2019)
  • 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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