K241707
- 510(k) number
- K241707
- Device name
- OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL
- Applicant
- Unicon Optical Co., Ltd. TW
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2024-07-12
- Date received
- 2024-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241707.pdf
Official FDA record: K241707
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.