Cleared Traditional

K961658 - MEGATRON OPHTHALMIC SURGICAL SYSTEM

K961658 is an FDA 510(k) clearance for MEGATRON OPHTHALMIC SURGICAL SYSTEM, manufactured by Intl. Ophthalmic Industries Corp.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K961658 · Intl. Ophthalmic Industries Corp. · Ophthalmic device
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Jul 1996
Decision
85d
Days
Class 2
Risk

K961658 is an FDA 510(k) clearance for the MEGATRON OPHTHALMIC SURGICAL SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Intl. Ophthalmic Industries Corp. (Centerville, US). The FDA issued a Cleared decision on July 23, 1996 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intl. Ophthalmic Industries Corp. devices

FDA 510(k) Submission Details - K961658

510(k) Number K961658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1996
Decision Date July 23, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HQC Unit, Phacofragmentation

All 197
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