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510(k) K023221

CONTACT LASER & DIAGNOSTIC LENSES by Volk Optical, Inc. — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
September 27, 2002
Clearance Type
Special
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

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  • K943125 — QUADRASPHERIC FUNDUS LENS (September 2, 1994)

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  • K142715 — Sensor Medical Family of Vitrectomy Lenses and Products (December 16, 2014)
  • K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET (June 29, 2005)
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  • 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)
  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)