# K152724: Eyeprintpro (Roflufocon D) Scleral GP Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vision Technologies
- Decided: Apr 27, 2016 after 218 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
Longest line of descent: 5 generations back to K943177 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070628: Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens., Contamac, Ltd. (2007) Summary page 5.
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses, Contamac, Ltd. (2004) Summary page 5.

## Indications for use
The EyePrintPRO (roflufocon D) Scleral GP Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K152724
Methodology: https://510kreport.com/methodology