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FDA 510(k)

EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO

K-Number: K020973 · 2002-03-29

ApplicantSurgilight, Inc.
Decision Date2002-03-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO is the device name listed in this FDA 510(k) record. The listed applicant is Surgilight, Inc.. It received FDA 510(k) clearance on 2002-03-29 under 510(k) number K020973. 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 EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO?

EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO is a medical device that received FDA 510(k) clearance on 2002-03-29. The listed applicant is Surgilight, Inc.. The 510(k) number is K020973.

When did EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO receive FDA 510(k) clearance?

EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO received FDA 510(k) clearance on 2002-03-29, under 510(k) number K020973.

Who is the listed applicant for EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO?

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

What is the FDA product code for EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO?

The FDA product code for EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Surgilight, Inc. 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.

K993328SURGILIGHT, INC EXCIMER LASER

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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