# K172314: Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

- Pathway: 510(k) (Traditional)
- Applicant: Art Optical Contact Lens, Inc.
- Decided: Sep 20, 2017 after 50 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K212631: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (2022), 7 descendants of its own
- K203571: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2021), 6 descendants of its own
- K223394: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) (2022), 5 descendants of its own
- K233325: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (2024), 4 descendants of its own
- K213538: Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2021), 4 descendants of its own

Source page: https://510kreport.com/device/K172314
Methodology: https://510kreport.com/methodology