Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IRRADIA MID - LASER (S3)

K-Number: K051548 · 2005-10-24

ApplicantIrradia AB
Decision Date2005-10-24
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IRRADIA MID - LASER (S3) is the device name listed in this FDA 510(k) record. The listed applicant is Irradia AB. It received FDA 510(k) clearance on 2005-10-24 under 510(k) number K051548. 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 IRRADIA MID - LASER (S3)?

IRRADIA MID - LASER (S3) is a medical device that received FDA 510(k) clearance on 2005-10-24. The listed applicant is Irradia AB. The 510(k) number is K051548.

When did IRRADIA MID - LASER (S3) receive FDA 510(k) clearance?

IRRADIA MID - LASER (S3) received FDA 510(k) clearance on 2005-10-24, under 510(k) number K051548.

Who is the listed applicant for IRRADIA MID - LASER (S3)?

The FDA 510(k) record lists Irradia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRRADIA MID - LASER (S3)?

The FDA product code for IRRADIA MID - LASER (S3) is ILY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: ILY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

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.

↑