# K161461: BostonSight PD Prosthetic Device

- Pathway: 510(k) (Traditional)
- Applicant: Bostonsight
- Decided: Jul 25, 2016 after 60 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
Longest line of descent: 6 generations back to K943177 (1994). 18 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153066: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens, Boston Foundation For Sight (2016) Summary page 6.
- P860022: Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens, Bausch & Lomb (1987) Summary page 6.

## Most influential descendants
- 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
- K212631: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (2022), 7 descendants of its own
- K203571: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2021), 6 descendants of its own
- K223394: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) (2022), 5 descendants of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-2191-2025: Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

## Indications for use
The Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for the management of a distorted corneal surface that: 1. precludes satisfactory spectacle lens correction 2. demonstrates significant improved rigid contact lens corrected vision 3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens Causes of corneal distortion include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann’s nodular degeneration), corneal dystrophy (e.g, lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma. The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjogren’s syndrome, dry eye syndrome), limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error. The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.

Source page: https://510kreport.com/device/K161461
Methodology: https://510kreport.com/methodology