Cleared Traditional

K993586 - SPORTSIGHT GP (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993586 · Paragon Vision Sciences · Ophthalmic device
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May 2000
Decision
213d
Days
Class 2
Risk

K993586 is an FDA 510(k) clearance for the SPORTSIGHT GP. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Paragon Vision Sciences (Mesa, US). The FDA issued a Cleared decision on May 22, 2000 after a review of 213 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 Paragon Vision Sciences devices

Submission Details

510(k) Number K993586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1999
Decision Date May 22, 2000
Days to Decision 213 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 110d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
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