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510(k) K022413

LUNEAU 3 MIRROR LENS by Luneau SA — Product Code HJK

K022413 is an FDA 510(k) premarket notification submitted by Luneau SA for the device "LUNEAU 3 MIRROR LENS". The FDA issued a decision of Substantially Equivalent on September 24, 2002. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. Luneau SA has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2002
Date Received
July 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type

Other clearances by Luneau SA

  • K162067 — VX130 Ophthalmic Diagnostic Device (April 24, 2017)
  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • K023838 — LUNEAU STERILE TONOMETER SEPARATION PRISMS (February 20, 2003)
  • K851557 — ANESTHESIOMETER (May 30, 1985)

Other clearances for product code HJK

  • K201909 — RxSight Contact Lens (September 10, 2020)
  • K173944 — Endocular Viewing Lenses and Silicone Ring (October 25, 2018)
  • K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (August 18, 2015)
  • K142715 — Sensor Medical Family of Vitrectomy Lenses and Products (December 16, 2014)
  • K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET (June 29, 2005)
  • K051103 — HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY (June 7, 2005)
  • K050623 — VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK (March 28, 2005)
  • K033950 — DORC VITRECTOMY LENSES, MODEL 1284 SERIES (February 20, 2004)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)

FDA data resources