Cleared Traditional

K925663 - HGM ASPIRATING ENDOOCULAR(TM) PROBE (FDA 510(k) Clearance)

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

K925663 · Hgm, Inc. · Ophthalmic device
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Aug 1993
Decision
280d
Days
Class 2
Risk

K925663 is an FDA 510(k) clearance for the HGM ASPIRATING ENDOOCULAR(TM) 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 August 17, 1993 after a review of 280 days - an extended review cycle.

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. 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 Hgm, Inc. devices

Submission Details

510(k) Number K925663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date August 17, 1993
Days to Decision 280 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
170d slower than avg
Panel avg: 110d · This submission: 280d
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.

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All 179
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