# K022128: Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Aug 22, 2002 after 52 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: 1 generation back to P860022 (1987). 1 ancestor in all.
24 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860022: Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens, Bausch & Lomb (1987) Summary page 1.

## Most influential descendants
- K153066: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens (2016), 20 descendants of its own
- K161461: BostonSight PD Prosthetic Device (2016), 19 descendants of its own
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (2017), 14 descendants of its own
- K180616: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (2018), 9 descendants of its own
- K212631: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (2022), 7 descendants of its own

## Indications for use
The BOSTON EQUALENS II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K022128
Methodology: https://510kreport.com/methodology