# K013646: Rose K Post Graft Lens

- Pathway: 510(k) (Traditional)
- Applicant: Rose K International, Ltd.
- Decided: May 30, 2002 after 206 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
No predicates in its family tree.
39 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A) and Rose K Post Graft Rigid Gas Permeable Contact Lens (enflufocon B) are indicated for correction of refractive errors following penetrating keratoplasty in nonaphakic persons. The lenses may be disinfected by chemical methods.

Source page: https://510kreport.com/device/K013646
Methodology: https://510kreport.com/methodology