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FDA 510(k)

MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM

K-Number: K041994 · 2004-10-06

ApplicantCurelight, Ltd.
Decision Date2004-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Curelight, Ltd.. It received FDA 510(k) clearance on 2004-10-06 under 510(k) number K041994. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM?

MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-06. The listed applicant is Curelight, Ltd.. The 510(k) number is K041994.

When did MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2004-10-06, under 510(k) number K041994.

Who is the listed applicant for MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM?

The FDA product code for MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Curelight, Ltd. 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.

K041569CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002K033183RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012K032383MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEMK030338ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002K013623CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420

Related Devices (Code: GEX)

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.

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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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