K231997 - SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) (FDA 510(k) Clearance)

K231997 is an FDA 510(k) clearance for the SIRONA 100 Therapy Laser System (OEM's Model EVANLAS). Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Cure Point Therapeutics, Inc. (Cheyenne, US). The FDA issued a Cleared decision on October 15, 2024 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - the FDA general and plastic surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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