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FDA 510(k)

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

K-Number: K231997 · 2024-10-15

ApplicantCure Point Therapeutics, Inc.
Decision Date2024-10-15
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is a medical device manufactured by Cure Point Therapeutics, Inc.. It received FDA 510(k) clearance on 2024-10-15 under approval number K231997. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is a medical device that received FDA 510(k) clearance on 2024-10-15. It is manufactured by Cure Point Therapeutics, Inc.. The 510(k) number is K231997.

When was SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) approved by the FDA?

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) received FDA 510(k) clearance on 2024-10-15, under approval number K231997.

What company makes SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is manufactured by Cure Point Therapeutics, Inc..

What is the FDA product code for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?

The FDA product code for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is ILY.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Related Devices (Code: ILY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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