Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)— 510(k) K172314
Substantially EquivalentArt Optical Contact Lens, Inc.
FDA 510(k) clearance K172314 for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D), Substantially Equivalent on 2017-09-20. Applicant: Art Optical Contact Lens, Inc.. Device class: 2.
Clearance details
- Applicant
- Art Optical Contact Lens, Inc.
- Product code
- Code HQD
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.