K242916
- 510(k) number
- K242916
- Device name
- Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
- Applicant
- Largan Medical Co., Ltd. TW
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2025-02-04
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242916.pdf
Official FDA record: K242916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.