510(k) K182523
K182523 is an FDA 510(k) premarket notification submitted by Largan Medical Co., Ltd. for the device "Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens". The FDA issued a decision of Substantially Equivalent on November 1, 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 1, 2018
- Date Received
- September 13, 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