K-number	K231997
Device name	SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
Applicant	Cure Point Therapeutics, Inc.
Product code	ILY
Device class	Class II
Decision date	Oct 15, 2024
Decision	Substantially Equivalent
Regulation	890.5500

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

Everything you need for a 510(k) submission. Nothing you don't.