# P860022: Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens

- Pathway: PMA
- Applicant: Bausch & Lomb
- Decided: Nov 30, 1987 after 546 days
- Product code: MWL (Lens, Contact (Rigid Gas Permeable), Extended Wear)
- Device class: 3
- 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.
25 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)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K022128: Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens (2002), 24 descendants of its own
- 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

Source page: https://510kreport.com/device/P860022
Methodology: https://510kreport.com/methodology