510(k) Report

FDA applicant

Bostonsight

Needham, MA2 decisions2016–20192 recalls

FDA records 2 decisions for Bostonsight (Needham, MA) from 2016 to 2019: 2 510(k) clearances. All are in product code HQD (Lens, Contact (Other Material) - Daily). Its devices cite 5 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Bostonsight’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 12019: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2025

2025: 2
2016high 2 (2025) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Bostonsight by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQDLens, Contact (Other Material) - Daily2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161461BostonSight PD Prosthetic DeviceBostonsight · 20165cite it
  • K183175BostonSight ScleralBostonsight · 20191cites it

What has FDA decided for it lately?

  • K183175BostonSight ScleralBostonsight · 20191 recall
  • K161461BostonSight PD Prosthetic DeviceBostonsight · 20161 recall

All 2 as Bostonsight →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K183175BostonSight SCLERAL LensJun 10, 2025Class II
  • K161461BostonSight PROSE Lens.Jun 10, 2025Class II