# K153066: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens

- Pathway: 510(k) (Traditional)
- Applicant: Boston Foundation For Sight
- Decided: Feb 9, 2016 after 110 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: 5 generations back to K943177 (1994). 17 ancestors in all.
20 later devices descend from it; 1 cites 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)
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses, Contamac, Ltd. (2004) Summary page 5.
- K022128: Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens, Bausch & Lomb, Incorporated (2002) Summary page 5.
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens, Bausch & Lomb, Inc. (2007) Summary page 5.

## Most influential descendants
- 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
- 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

## Indications for use
The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K153066
Methodology: https://510kreport.com/methodology