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FDA 510(k)

ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002

K-Number: K030338 · 2003-02-12

ApplicantCurelight, Ltd.
Decision Date2003-02-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICLEAR 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 2003-02-12 under 510(k) number K030338. 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 ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002?

ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 is a medical device that received FDA 510(k) clearance on 2003-02-12. The listed applicant is Curelight, Ltd.. The 510(k) number is K030338.

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

ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 received FDA 510(k) clearance on 2003-02-12, under 510(k) number K030338.

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

The FDA product code for ICLEAR 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.

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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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