Cleared Traditional

K051103 - HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY

K051103 is an FDA 510(k) clearance for HAAG-STREIT CONTACT GLASSES STERY CUP, manufactured by Haag-Streit USA, Inc.. The device is a Class 2 Ophthalmic device with product code HJK cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K051103 · Haag-Streit USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
39d
Days
Class 2
Risk

K051103 is an FDA 510(k) clearance for the HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Haag-Streit USA, Inc. (Rockville, US). The FDA issued a Cleared decision on June 7, 2005 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051103

510(k) Number K051103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2005
Decision Date June 07, 2005
Days to Decision 39 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 110d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJK Device Classification - Class 2, Special Controls

Product Code HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 40
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K051103.
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K050623 · Volk Optical, Inc. · Mar 2005
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K033950 · Dutch Ophthalmic Research Center (D.O.R.C.) · Feb 2004
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K030054 · Fci Ophthalmics, Inc. · Feb 2003
K051103 · HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
Download PDF FDA Summary Haag-Streit USA, Inc.