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)

PHOTOTHERAPY LAMP

K-Number: K984589 · 1999-04-20

ApplicantMedela, Inc.
Decision Date1999-04-20
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHOTOTHERAPY LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1999-04-20 under 510(k) number K984589. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTOTHERAPY LAMP?

PHOTOTHERAPY LAMP is a medical device that received FDA 510(k) clearance on 1999-04-20. The listed applicant is Medela, Inc.. The 510(k) number is K984589.

When did PHOTOTHERAPY LAMP receive FDA 510(k) clearance?

PHOTOTHERAPY LAMP received FDA 510(k) clearance on 1999-04-20, under 510(k) number K984589.

Who is the listed applicant for PHOTOTHERAPY LAMP?

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

What is the FDA product code for PHOTOTHERAPY LAMP?

The FDA product code for PHOTOTHERAPY LAMP is LBI.

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 Medela, 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.

K161811Medela Low Dose Enteral SyringeK161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailK031614MEDELA PUMP IN STYLE ADVANCED BREAST PUMPK020518MEDELA SYMPHONY BREAST PUMP, MODEL 024K983552BASIC, MEDIAN, DOMINANT, AND VARIOK962612BILIBED PHOTOTHERAPY LAMP

View all 19 devices →

Related Devices (Code: LBI)

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.

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical ProductsK243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated

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.

↑