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)

INFRALUX HEAT LAMP

K-Number: K864714 · 1987-03-12

ApplicantInfralux International, Inc.
Decision Date1987-03-12
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

INFRALUX HEAT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Infralux International, Inc.. It received FDA 510(k) clearance on 1987-03-12 under 510(k) number K864714. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INFRALUX HEAT LAMP?

INFRALUX HEAT LAMP is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is Infralux International, Inc.. The 510(k) number is K864714.

When did INFRALUX HEAT LAMP receive FDA 510(k) clearance?

INFRALUX HEAT LAMP received FDA 510(k) clearance on 1987-03-12, under 510(k) number K864714.

Who is the listed applicant for INFRALUX HEAT LAMP?

The FDA 510(k) record lists Infralux International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFRALUX HEAT LAMP?

The FDA product code for INFRALUX HEAT LAMP 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

Other records listing Infralux International, Inc. as applicant

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.

K900384INFRAVIB MASSAGER - MODEL PR-1000

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.

↑