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FDA 510(k)

OMNILUX PLUS

K-Number: K043317 · 2005-03-15

ApplicantPhoto Therapeutics Limited
Decision Date2005-03-15
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMNILUX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Photo Therapeutics Limited. It received FDA 510(k) clearance on 2005-03-15 under 510(k) number K043317. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNILUX PLUS?

OMNILUX PLUS is a medical device that received FDA 510(k) clearance on 2005-03-15. The listed applicant is Photo Therapeutics Limited. The 510(k) number is K043317.

When did OMNILUX PLUS receive FDA 510(k) clearance?

OMNILUX PLUS received FDA 510(k) clearance on 2005-03-15, under 510(k) number K043317.

Who is the listed applicant for OMNILUX PLUS?

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

What is the FDA product code for OMNILUX PLUS?

The FDA product code for OMNILUX PLUS is ILY.

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 Photo Therapeutics Limited 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.

K050216OMNILUX REVIVE AND OMNILUX PLUSK043329OMNILUX REVIVE AND BLUEK030426OMNILUX REDK030883OMNILUX BLUE

Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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