# K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B)  and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses

- Pathway: 510(k) (Abbreviated)
- Applicant: Bausch & Lomb, Inc.
- Decided: Aug 2, 2007 after 112 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943177 (1994). 7 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses, Bausch & Lomb, Incorporated (2006) Summary page 1.
- K013762: Rigid Gas Permeable Contact Lens, Bausch & Lomb, Incorporated (2002) Summary page 1.

## Most influential descendants
- 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
- K233325: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (2024), 4 descendants of its own

## Recalls of this device
- Jul 3, 2018 · Class III · Z-2982-2018: Vials labeled for the prescriptions contained incorrect lenses
- Jul 3, 2018 · Class III · Z-2981-2018: Vials labeled for the prescriptions contained incorrect lenses

## Indications for use
Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses are 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. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid 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.

Source page: https://510kreport.com/device/K071043
Methodology: https://510kreport.com/methodology