# K011945: Rigid Gas Permeable Contact Lens Solution

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Corp.
- Decided: Sep 12, 2001 after 83 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 K002025 (2000). 1 ancestor in all.
27 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002025: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) 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
- K180616: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (2018), 9 descendants of its own

## Indications for use
BOSTON EQUALENS (itafluorofocon A) and BOSTON EQUALENS Ii (oprifocon A) RGP 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 nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

Source page: https://510kreport.com/device/K011945
Methodology: https://510kreport.com/methodology