# K943177: Boston (R) 7 - 30(Enflufocon a)

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Corp.
- Decided: Aug 25, 1994 after 55 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
54 later devices descend from it; 6 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K000795: Rigid Gas Permeable Contact Lens (2000), 50 descendants of its own
- 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
- K970698: Boston ES Multivision (Enflufocon a) Contact Lens (1997), 30 descendants of its own
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses (2004), 28 descendants of its own

## Recalls of this device
- Apr 20, 2010 · Not classified · Z-1705-2010: The amount of D&C #6 Dye added to the formulation exceeded specified amounts.

Source page: https://510kreport.com/device/K943177
Methodology: https://510kreport.com/methodology