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FDA 510(k)

RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012

K-Number: K033183 · 2004-04-15

ApplicantCurelight, Ltd.
Decision Date2004-04-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 is the device name listed in this FDA 510(k) record. The listed applicant is Curelight, Ltd.. It received FDA 510(k) clearance on 2004-04-15 under 510(k) number K033183. 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 RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012?

RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 is a medical device that received FDA 510(k) clearance on 2004-04-15. The listed applicant is Curelight, Ltd.. The 510(k) number is K033183.

When did RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 receive FDA 510(k) clearance?

RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 received FDA 510(k) clearance on 2004-04-15, under 510(k) number K033183.

Who is the listed applicant for RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012?

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 RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012?

The FDA product code for RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 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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