510(k) K182674
K182674 is an FDA 510(k) premarket notification submitted by Largan Medical Co., Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on November 13, 2018. 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
- 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