Cleared Traditional

K010454 - THE ALBERTA LENS SM2, SULFOCON B

K010454 is an FDA 510(k) clearance for THE ALBERTA LENS SM2, manufactured by Progressive Optical Research , Ltd.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K010454 · Progressive Optical Research , Ltd. · Ophthalmic device
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Aug 2001
Decision
167d
Days
Class 2
Risk

K010454 is an FDA 510(k) clearance for the THE ALBERTA LENS SM2, SULFOCON B. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Progressive Optical Research , Ltd. (Calgary, Alberta, CA). The FDA issued a Cleared decision on August 1, 2001 after a review of 167 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Progressive Optical Research , Ltd. devices

FDA 510(k) Submission Details - K010454

510(k) Number K010454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2001
Decision Date August 01, 2001
Days to Decision 167 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 110d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 82
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K010454.
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