TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Lenses, Soft Contact, Daily Wear

DK Medivision Co., Ltd.

The following data is part of a premarket notification filed by Dk Medivision Co., Ltd. with the FDA for Trevues (polymacon) Soft (hydrophilic) Contact Lenses (tinted, Color).

Pre-market Notification Details

• Device ID: K220045
• 510k Number: K220045
• Device Name: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
• Classification: Lenses, Soft Contact, Daily Wear
• Applicant: DK Medivision Co., Ltd. 23 Busong 1-gil, Jiksan-eup Chungcheongnam-do, KR 31038
• Contact: Henry Hong
• Correspondent: Bret Andre; EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068
• Product Code: LPL
• CFR Regulation Number: 886.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-05
• Decision Date: 2022-08-05

NIH GUDID Devices

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