Home / 510(k) Clearances / K033950

510(k) K033950

DORC VITRECTOMY LENSES, MODEL 1284 SERIES by Dutch Ophthalmic Research Center (D.O.R.C.) — Product Code HJK

K033950 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic Research Center (D.O.R.C.) for the device "DORC VITRECTOMY LENSES, MODEL 1284 SERIES". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
December 22, 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 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)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)
  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)

FDA data resources