Cleared Traditional

K925741 - CLARUS ENDOSCOPIC HOOK KNIFE

K925741 is an FDA 510(k) clearance for CLARUS ENDOSCOPIC HOOK KNIFE, manufactured by Clarus Medical Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HLX cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K925741 · Clarus Medical Systems, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Aug 1993
Decision
284d
Days
Class 2
Risk

K925741 is an FDA 510(k) clearance for the CLARUS ENDOSCOPIC HOOK KNIFE. Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 284 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1630 - 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 Clarus Medical Systems, Inc. devices

FDA 510(k) Submission Details - K925741

510(k) Number K925741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1992
Decision Date August 24, 1993
Days to Decision 284 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 110d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLX Device Classification - Class 2, Special Controls

Product Code HLX Photostimulator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1630
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 - HLX Photostimulator, Ac-powered

Devices cleared under the same product code (HLX) and FDA review panel - the closest regulatory comparables to K925741.
LED GOGGLES
K831231 · Cadwell Laboratories, Inc. · May 1983
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K830770 · Cadwell Laboratories, Inc. · Apr 1983
5031 BRIGHT FLASH STIMULATOR
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5010 VISUSTIM
K822919 · Life-Tech Intl., Inc. · Dec 1982
5011 GANZFELD STIMULATOR
K822922 · Life-Tech Intl., Inc. · Dec 1982
5012 PARABOLIC STIMULATOR
K822923 · Life-Tech Intl., Inc. · Dec 1982