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)

SUNBURST, SUN SYSTEMS OR BC2

K-Number: K801163 · 1980-07-21

ApplicantSun Ray Mfg., Inc.
Decision Date1980-07-21
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNBURST, SUN SYSTEMS OR BC2 is the device name listed in this FDA 510(k) record. The listed applicant is Sun Ray Mfg., Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801163. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNBURST, SUN SYSTEMS OR BC2?

SUNBURST, SUN SYSTEMS OR BC2 is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Sun Ray Mfg., Inc.. The 510(k) number is K801163.

When did SUNBURST, SUN SYSTEMS OR BC2 receive FDA 510(k) clearance?

SUNBURST, SUN SYSTEMS OR BC2 received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801163.

Who is the listed applicant for SUNBURST, SUN SYSTEMS OR BC2?

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

What is the FDA product code for SUNBURST, SUN SYSTEMS OR BC2?

The FDA product code for SUNBURST, SUN SYSTEMS OR BC2 is LEJ.

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: LEJ)

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.

K221523Tanning LampUnilam Co., Ltd.K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbHK191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbHK190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbHK183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbHK180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH

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.

↑