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)

UVA PHOTOTHERAPY SYSTEM

K-Number: K761094 · 1976-12-02

ApplicantDermatron Corp.
Decision Date1976-12-02
Product CodeKGL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UVA PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dermatron Corp.. It received FDA 510(k) clearance on 1976-12-02 under 510(k) number K761094. The device is classified under product code KGL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UVA PHOTOTHERAPY SYSTEM?

UVA PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1976-12-02. The listed applicant is Dermatron Corp.. The 510(k) number is K761094.

When did UVA PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

UVA PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 1976-12-02, under 510(k) number K761094.

Who is the listed applicant for UVA PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for UVA PHOTOTHERAPY SYSTEM?

The FDA product code for UVA PHOTOTHERAPY SYSTEM is KGL.

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 Dermatron Corp. 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.

K770862BLACK LAMPS,F72T12/BL/HOK760482SUNLAMP (F40-UVB & F20-UVB)K760471LAMP, FLOURESCENT BLACK, HIGH OUTPUTK760519SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313

Related Devices (Code: KGL)

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.

K852575WALDMANN F85/100W PUVASylvania Lighting ProductsK841795UV 8001K, PUVA 800, PUVA 180/200 1000Waldmann Lighting Co.K820280SPECTRA 305/350UltraliteK810668HO-B-LITE VI UNITNational Biological Corp.K810358PHOTOTHERAPY LIGHT CHAMBERPaul B. Elder Co.K791977PSORALITE MARK IPaul B. Elder Co.

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.

↑