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FDA 510(k)

CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420

K-Number: K013623 · 2002-08-16

ApplicantCurelight, Ltd.
Decision Date2002-08-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 is the device name listed in this FDA 510(k) record. The listed applicant is Curelight, Ltd.. It received FDA 510(k) clearance on 2002-08-16 under 510(k) number K013623. 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 CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420?

CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 is a medical device that received FDA 510(k) clearance on 2002-08-16. The listed applicant is Curelight, Ltd.. The 510(k) number is K013623.

When did CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 receive FDA 510(k) clearance?

CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 received FDA 510(k) clearance on 2002-08-16, under 510(k) number K013623.

Who is the listed applicant for CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420?

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 CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420?

The FDA product code for CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 is GEX. This falls under the Gastroenterology category.

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Other records listing Curelight, Ltd. as applicant

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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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