# K181579: eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K

- Pathway: 510(k) (Traditional)
- Applicant: E&E Optics, Inc.
- Decided: Jul 26, 2018 after 41 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001960: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 5.
- K003933: Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy, Polymer Technology (2001) Summary page 5.
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens, Bausch & Lomb, Inc. (2007) Summary page 5.
- K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B)  and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses, Bausch & Lomb, Inc. (2007) Summary page 5.
- K170001: Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2017) Summary page 5.

## Indications for use
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only. The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Source page: https://510kreport.com/device/K181579
Methodology: https://510kreport.com/methodology