# K980741: Boston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B)

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Div. Wilmington Partners, L.P.
- Decided: May 11, 1998 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K170007: Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens (2017), 0 descendants of its own

## Indications for use
BOSTON EO (enflufocon B) 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/K980741
Methodology: https://510kreport.com/methodology