Cleared Traditional

K142398 - Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow

K142398 is an FDA 510(k) clearance for Integre Pro Scan Green, 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 321-day FDA review.

K142398 · Ellex Medical Pty, Ltd. · Ophthalmic device
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Jul 2015
Decision
321d
Days
Class 2
Risk

K142398 is an FDA 510(k) clearance for the Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, .... Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Ellex Medical Pty, Ltd. (Adelaide, AU). The FDA issued a Cleared decision on July 14, 2015 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ellex Medical Pty, Ltd. devices

FDA 510(k) Submission Details - K142398

510(k) Number K142398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date July 14, 2015
Days to Decision 321 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 110d · This submission: 321d
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 153
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