# K013762: Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Apr 3, 2002 after 141 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.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820065: Boston Lens (R) Lens - Clear, Polymer Technology Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P820065/S001 (Dec 23, 1983). Summary page 1.

## Most influential descendants
- K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B)  and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses (2007), 14 descendants of its own
- K162005: Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (2016), 9 descendants of its own
- K201194: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2020), 7 descendants of its own
- K203571: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2021), 6 descendants of its own
- K183167: Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens (2019), 5 descendants of its own

## Indications for use
The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K013762
Methodology: https://510kreport.com/methodology