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FDA 510(k)

LUNEAU 3 MIRROR LENS

K-Number: K022413 · 2002-09-24

ApplicantLuneau SA
Decision Date2002-09-24
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LUNEAU 3 MIRROR LENS is the device name listed in this FDA 510(k) record. The listed applicant is Luneau SA. It received FDA 510(k) clearance on 2002-09-24 under 510(k) number K022413. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNEAU 3 MIRROR LENS?

LUNEAU 3 MIRROR LENS is a medical device that received FDA 510(k) clearance on 2002-09-24. The listed applicant is Luneau SA. The 510(k) number is K022413.

When did LUNEAU 3 MIRROR LENS receive FDA 510(k) clearance?

LUNEAU 3 MIRROR LENS received FDA 510(k) clearance on 2002-09-24, under 510(k) number K022413.

Who is the listed applicant for LUNEAU 3 MIRROR LENS?

The FDA 510(k) record lists Luneau SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUNEAU 3 MIRROR LENS?

The FDA product code for LUNEAU 3 MIRROR LENS is HJK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Luneau SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023838LUNEAU STERILE TONOMETER SEPARATION PRISMSK851557ANESTHESIOMETER

Related Devices (Code: HJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201909RxSight Contact LensRxsight, Inc.K173944Endocular Viewing Lenses and Silicone RingPhakosK051630SUPER VIEW DISPOSABLE BIOM LENS SETInsight Instruments, Inc.K051103HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYHaag-Streit USA, Inc.K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.K033950DORC VITRECTOMY LENSES, MODEL 1284 SERIESDutch Ophthalmic Research Center (D.O.R.C.)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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