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FDA 510(k)

CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002

K-Number: K041569 · 2004-06-30

ApplicantCurelight, Ltd.
Decision Date2004-06-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 is the device name listed in this FDA 510(k) record. The listed applicant is Curelight, Ltd.. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K041569. 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 CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002?

CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is Curelight, Ltd.. The 510(k) number is K041569.

When did CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 receive FDA 510(k) clearance?

CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 received FDA 510(k) clearance on 2004-06-30, under 510(k) number K041569.

Who is the listed applicant for CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002?

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 CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002?

The FDA product code for CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 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.

K041994MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEMK033183RECLEAR 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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