K242393
- 510(k) number
- K242393
- Device name
- Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
- Applicant
- Acuity Polymers, Inc. NY · US
- Product code
- HQD — Lens, Contact (Other Material) - Daily
- Decision date
- 2024-11-01
- Date received
- 2024-08-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242393.pdf
Official FDA record: K242393
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.