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FDA 510(k)

PHOTOTHERAPY LIGHT CHAMBER

K-Number: K810358 · 1981-03-20

ApplicantPaul B. Elder Co.
Decision Date1981-03-20
Product CodeKGL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTOTHERAPY LIGHT CHAMBER 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 1981-03-20 under 510(k) number K810358. 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 PHOTOTHERAPY LIGHT CHAMBER?

PHOTOTHERAPY LIGHT CHAMBER is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is Paul B. Elder Co.. The 510(k) number is K810358.

When did PHOTOTHERAPY LIGHT CHAMBER receive FDA 510(k) clearance?

PHOTOTHERAPY LIGHT CHAMBER received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810358.

Who is the listed applicant for PHOTOTHERAPY LIGHT CHAMBER?

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 PHOTOTHERAPY LIGHT CHAMBER?

The FDA product code for PHOTOTHERAPY LIGHT CHAMBER 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.

K791977PSORALITE MARK IK791116PSORALITE 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.K791977PSORALITE MARK IPaul 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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