510(k) K220045
K220045 is an FDA 510(k) premarket notification submitted by Dk Medivision Co., Ltd. for the device "TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)". The FDA issued a decision of Substantially Equivalent on Aug 5, 2022. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2022
- Date Received
- Jan 5, 2022
- 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
- 510(k)