510(k) K242916
K242916 is an FDA 510(k) premarket notification submitted by Largan Medical Co., Ltd. for the device "Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens". The FDA issued a decision of Substantially Equivalent on February 4, 2025. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Largan Medical Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2025
- Date Received
- September 24, 2024
- 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