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510(k) K051103

HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY by Haag-Streit USA, Inc. — Product Code HJK

K051103 is an FDA 510(k) premarket notification submitted by Haag-Streit USA, Inc. for the device "HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY". The FDA issued a decision of Substantially Equivalent on June 7, 2005. 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
June 7, 2005
Date Received
April 29, 2005
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

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  • 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)
  • 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)
  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)

FDA data resources