# K000795: Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology
- Decided: May 26, 2000 after 74 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 K943177 (1994). 1 ancestor in all.
50 later devices descend from it; 7 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943177: Boston (R) 7 - 30(Enflufocon a), Polymer Technology Corp. (1994) Summary page 3.

## Most influential descendants
- K020006: Dyna Intra-Limbal Lens (2002), 39 descendants of its own
- K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses (2006), 38 descendants of its own
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses (2004), 28 descendants of its own
- 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

## Indications for use
BOSTON XO (hexafocon A) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

Source page: https://510kreport.com/device/K000795
Methodology: https://510kreport.com/methodology