# K970698: Boston ES Multivision (Enflufocon a) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Corp.
- Decided: May 6, 1997 after 70 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 K942365 (1994). 2 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 33 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 2.
- K942365: Boston Vii, Polymer Technology Corp. (1994) Summary page 2.
- (no number) BAUSCH & LOMB Occasions™ (polymacon) Visibility Tinted Multifocal Contact Lens: named in the summary without a submission number

## Most influential descendants
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses (2004), 28 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
The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with non-diseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only.

Source page: https://510kreport.com/device/K970698
Methodology: https://510kreport.com/methodology