LUNEAU 3 MIRROR LENS— 510(k) K022413

Substantially Equivalent

Luneau SA

FDA 510(k) clearance K022413 for LUNEAU 3 MIRROR LENS, Substantially Equivalent on 2002-09-24. Applicant: Luneau SA. Device class: 2.

Clearance details

Applicant: Luneau SA
Product code: Code HJK
Device class: Class 2
Regulation: 21 CFR 886.1385
Advisory panel: Ophthalmic
Date received: 2002-07-24
Decision date: 2002-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chartres Cedex, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HJK

K201909 — RxSight Contact Lens2020-09-10
K173944 — Endocular Viewing Lenses and Silicone Ring2018-10-25
K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens2015-08-18
K142715 — Sensor Medical Family of Vitrectomy Lenses and Products2014-12-16
K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET2005-06-29

More clearances from Luneau SA

K023838 — LUNEAU STERILE TONOMETER SEPARATION PRISMS2003-02-20
K851557 — ANESTHESIOMETER1985-05-30

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