Cleared Special

LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA (K001772) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001772 · Taracan Pty. , Ltd. · Ophthalmic device
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Jul 2000
Decision
24d
Days
Class 2
Risk

K001772 is an FDA 510(k) clearance for the LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Taracan Pty. , Ltd. (Adelaide, South Australia, AU). The FDA issued a Cleared decision on July 6, 2000 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Taracan Pty. , Ltd. devices

Submission Details

510(k) Number K001772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date July 06, 2000
Days to Decision 24 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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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