# K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Jan 30, 2006 after 84 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: 3 generations back to K943177 (1994). 4 ancestors in all.
38 later devices descend from it; 8 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020006: Dyna Intra-Limbal Lens, Lens Dynamics, Inc. (2002) Summary page 1.
- K013646: Rose K Post Graft Lens, Rose K International, Ltd. (2002) Summary page 1.

## Most influential descendants
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens (2007), 26 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
- 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

## 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) 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/K053124
Methodology: https://510kreport.com/methodology