# K020006: Dyna Intra-Limbal Lens

- Pathway: 510(k) (Traditional)
- Applicant: Lens Dynamics, Inc.
- Decided: Mar 29, 2002 after 86 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: 2 generations back to K943177 (1994). 2 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 42 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 1.
- K000795: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular comeal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty. The lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K020006
Methodology: https://510kreport.com/methodology