Cleared Traditional

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo (K222395) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222395 · Ellex Medical Pty, Ltd. · Ophthalmic device
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Nov 2022
Decision
86d
Days
Class 2
Risk

K222395 is an FDA 510(k) clearance for the Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo. 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 November 2, 2022 after a review of 86 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

Submission Details

510(k) Number K222395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2022
Decision Date November 02, 2022
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

O`Connell Regulatory Consultants, Inc.
Maureen O`Connell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQF Laser, Ophthalmic

All 29
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