Cleared Traditional

K955158 - SURGITRON

K955158 is an FDA 510(k) clearance for SURGITRON, manufactured by Ellman Intl., Inc.. The device is a Class 2 Ophthalmic device with product code HQR cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K955158 · Ellman Intl., Inc. · Ophthalmic device
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Feb 1996
Decision
88d
Days
Class 2
Risk

K955158 is an FDA 510(k) clearance for the SURGITRON. Classified as Apparatus, Cautery, Radiofrequency, Ac-powered (product code HQR), Class II - Special Controls.

Submitted by Ellman Intl., Inc. (Sound Beach, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - 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 Ellman Intl., Inc. devices

FDA 510(k) Submission Details - K955158

510(k) Number K955158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date February 09, 1996
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQR Device Classification - Class 2, Special Controls

Product Code HQR Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
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 - HQR Apparatus, Cautery, Radiofrequency, Ac-powered

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K895800 · Advanced Surgical Products, Inc. · Jan 1990