Cleared Traditional

K972514 - LASEREX LP1532 PHOTOCOAGULATOR

K972514 is an FDA 510(k) clearance for LASEREX LP1532 PHOTOCOAGULATOR, manufactured by Ellex Medical Pty, Ltd.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K972514 · Ellex Medical Pty, Ltd. · Ophthalmic device
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Oct 1997
Decision
88d
Days
Class 2
Risk

K972514 is an FDA 510(k) clearance for the LASEREX LP1532 PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Ellex Medical Pty, Ltd. (Adelaide, South Australia, AU). The FDA issued a Cleared decision on October 3, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Ellex Medical Pty, Ltd. devices

FDA 510(k) Submission Details - K972514

510(k) Number K972514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date October 03, 1997
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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 86
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K972514.
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