Home / 510(k) Clearances / K182674

510(k) K182674

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia by Largan Medical Co., Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2018
Date Received
September 26, 2018
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 Largan Medical Co., Ltd.

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  • K202129 — Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, L (April 1, 2021)
  • K182523 — Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (November 1, 2018)
  • K181232 — Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (June 29, 2018)
  • K181230 — Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (June 25, 2018)
  • K170286 — Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxi (September 18, 2017)

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