BostonSight IC Corneal Lens, BostonSight IC Scleral Lens— 510(k) K153066

Name: FDA 510(k) clearance K153066
Creator: U.S. Food and Drug Administration
Published: 2016-02-09

Substantially Equivalent

Boston Foundation For Sight

FDA 510(k) clearance K153066 for BostonSight IC Corneal Lens, BostonSight IC Scleral Lens, Substantially Equivalent on 2016-02-09. Applicant: Boston Foundation For Sight. Device class: 2.

Clearance details

Applicant: Boston Foundation For Sight
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2015-10-22
Decision date: 2016-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQD

view all

K253822 — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses2026-03-27
K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses2024-11-01
K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses2024-10-22
K241571 — BostonSight® Specialty Lenses2024-08-14
K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more2024-04-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.