Cleared Traditional

K860358 - FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (ST...

K860358 is an FDA 510(k) clearance for FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (ST..., manufactured by Hgm, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K860358 · Hgm, Inc. · Ophthalmic device
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Mar 1986
Decision
50d
Days
Class 2
Risk

K860358 is an FDA 510(k) clearance for the FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE). 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 21, 1986 after a review of 50 days - a notably fast clearance 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: 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 Hgm, Inc. devices

FDA 510(k) Submission Details - K860358

510(k) Number K860358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1986
Decision Date March 21, 1986
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

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 82
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