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FDA 510(k)

ULTRALITE PANELITE

K-Number: K910091 · 1991-05-30

ApplicantUltralite
Decision Date1991-05-30
Product CodeIOB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRALITE PANELITE is the device name listed in this FDA 510(k) record. The listed applicant is Ultralite. It received FDA 510(k) clearance on 1991-05-30 under 510(k) number K910091. The device is classified under product code IOB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRALITE PANELITE?

ULTRALITE PANELITE is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is Ultralite. The 510(k) number is K910091.

When did ULTRALITE PANELITE receive FDA 510(k) clearance?

ULTRALITE PANELITE received FDA 510(k) clearance on 1991-05-30, under 510(k) number K910091.

Who is the listed applicant for ULTRALITE PANELITE?

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

What is the FDA product code for ULTRALITE PANELITE?

The FDA product code for ULTRALITE PANELITE is IOB.

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 Ultralite 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.

K861963ULTRALITE HF1236 HAND AND FOOT SYSTEMK820492SPECTRA305K820280SPECTRA 305/350K827123SPECTRA (ULTRAVIOLET PRODUCTS)K761179PSORALITE

Related Devices (Code: IOB)

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.

K903660DERMALIGHT PSORACOMBSolitec GmbHK842276SUNMASTERMt. Hood Mfr., Inc.K813451UVA FLUORESCENT TANNING LAMPSNorth American Philips Corp.K812853OSRAM UVA LAMPOsram GmbHK760519SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313Dermatron Corp.

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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