Cleared Traditional

K840590 - FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE

K840590 is an FDA 510(k) clearance for FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE, 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 90-day FDA review.

K840590 · Hgm, Inc. · Ophthalmic device
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May 1984
Decision
90d
Days
Class 2
Risk

K840590 is an FDA 510(k) clearance for the FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Hgm, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K840590

510(k) Number K840590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1984
Decision Date May 09, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K840590.
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
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MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
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MODEL 4000 MD-YAG LASER FOR MALIGNANT
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MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · Cooper Lasersonics, Inc. · Apr 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · Nidek, Inc. · Mar 1984
MODEL 900S INTRAOCULAR PROBE
K812219 · Lumenis, Inc. · Nov 1981