Cleared Traditional

K823088 - ASPITRON

K823088 is the FDA 510(k) clearance for ASPITRON by Intl. Ophthalmic Industries Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K823088 · Intl. Ophthalmic Industries Corp. · Ophthalmic device
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Apr 1983
Decision
169d
Days
Class 2
Risk

K823088 is an FDA 510(k) clearance for the ASPITRON. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Intl. Ophthalmic Industries Corp. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 169 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Intl. Ophthalmic Industries Corp. devices

Submission Details

510(k) Number K823088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date April 06, 1983
Days to Decision 169 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 110d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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.