K240618
- 510(k) number
- K240618
- Device name
- Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
- Applicant
- Acuity Polymers, Inc. NY · US
- Product code
- HQD — Lens, Contact (Other Material) - Daily
- Decision date
- 2024-04-03
- Date received
- 2024-03-05
- 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: K240618.pdf
Official FDA record: K240618
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.