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510(k) K030054

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES by Fci Ophthalmics, Inc. — Product Code HJK

K030054 is an FDA 510(k) premarket notification submitted by Fci Ophthalmics, Inc. for the device "DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES". The FDA issued a decision of Substantially Equivalent on February 26, 2003. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. Fci Ophthalmics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2003
Date Received
January 6, 2003
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 Fci Ophthalmics, Inc.

  • K061404 — MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (August 7, 2006)
  • K061398 — SNUG PLUG PUNCTUM PLUG (July 11, 2006)
  • K041869 — SELF RETAINING BICANALICULUS INTUBATION SET (November 18, 2004)
  • K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (September 17, 2003)
  • K023400 — FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (August 22, 2003)
  • K992294 — BIOCERAMIC ORBITAL IMPLANT (April 19, 2000)
  • K991238 — FCI CRAWFORD PROBE INTUBATION SETS (July 8, 1999)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K980822 — TITANIUM PEG SYSTEM (July 9, 1998)
  • K964774 — PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (December 20, 1996)

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)
  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)
  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)

FDA data resources