# K183175: BostonSight Scleral

- Pathway: 510(k) (Traditional)
- Applicant: Bostonsight
- Decided: Jan 4, 2019 after 49 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: 9 generations back to K943177 (1994). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B), Bausch + Lomb, Incorporated (2017) Summary page 5.
- K180616: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens, Contamac, Ltd. (2018) Summary page 5.
- K161461: BostonSight PD Prosthetic Device, Bostonsight (2016) Summary page 5.

## Most influential descendants
- K241571: BostonSight® Specialty Lenses (2024), 0 descendants of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-2190-2025: Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

## Indications for use
BostonSight Scleral daily wear contact lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons. Also, the lenses may be prescribed in eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, keratoglobus, post-LASIK ectasia, or following penetrating keratoplasty or refractive surgery. Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. BostonSight Scleral daily wear contact lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject: 1. cannot be adequately corrected with spectacle lenses 2. requires a rigid gas permeable contact lens surface to improve vision 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities Common causes of corneal distortion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The BostonSight Scleral daily wear contact lenses are also indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjégren’s syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), 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 a distorted cornea or ocular surface disease, the BostonSight Scleral daily wear contact lenses may concurrently provide correction of refractive error. The lenses may be disinfected using a chemical disinfection (not heat) system only.

Source page: https://510kreport.com/device/K183175
Methodology: https://510kreport.com/methodology