ROSE K POST GRAFT LENS— 510(k) K013646

Name: FDA 510(k) clearance K013646
Creator: U.S. Food and Drug Administration
Published: 2002-05-30

Substantially Equivalent

Rose K International , Ltd.

FDA 510(k) clearance K013646 for ROSE K POST GRAFT LENS, Substantially Equivalent on 2002-05-30. Applicant: Rose K International , Ltd.. Device class: 2.

Clearance details

Applicant: Rose K International , Ltd.
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2001-11-05
Decision date: 2002-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamilton, NZ

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

More clearances from Rose K International , Ltd.

view all

K945955 — ROSE K LENS1995-02-07

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