Cleared Traditional

K931784 - HGM ILLUMINATING IMAGING ENDOCULAR PROBE (FDA 510(k) Clearance)

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

K931784 · Hgm, Inc. · Ophthalmic device
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Mar 1994
Decision
326d
Days
Class 2
Risk

K931784 is an FDA 510(k) clearance for the HGM ILLUMINATING IMAGING ENDOCULAR PROBE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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. Elevated predicate reliance profile. 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 Hgm, Inc. devices

Submission Details

510(k) Number K931784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1993
Decision Date March 01, 1994
Days to Decision 326 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
216d slower than avg
Panel avg: 110d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 - HQF Laser, Ophthalmic

All 179
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