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FDA 510(k)

PSORALITE MARK I

K-Number: K791977 · 1979-12-28

ApplicantPaul B. Elder Co.
Decision Date1979-12-28
Product CodeKGL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PSORALITE MARK I is the device name listed in this FDA 510(k) record. The listed applicant is Paul B. Elder Co.. It received FDA 510(k) clearance on 1979-12-28 under 510(k) number K791977. 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 PSORALITE MARK I?

PSORALITE MARK I is a medical device that received FDA 510(k) clearance on 1979-12-28. The listed applicant is Paul B. Elder Co.. The 510(k) number is K791977.

When did PSORALITE MARK I receive FDA 510(k) clearance?

PSORALITE MARK I received FDA 510(k) clearance on 1979-12-28, under 510(k) number K791977.

Who is the listed applicant for PSORALITE MARK I?

The FDA 510(k) record lists Paul B. Elder Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSORALITE MARK I?

The FDA product code for PSORALITE MARK I 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 Paul B. Elder Co. 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.

K810358PHOTOTHERAPY LIGHT CHAMBERK791116PSORALITE SERIES 30,000

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.K791116PSORALITE SERIES 30,000Paul 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.

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