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FDA 510(k)

SURGILIGHT, INC EXCIMER LASER

K-Number: K993328 · 2000-07-18

ApplicantSurgilight, Inc.
Decision Date2000-07-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGILIGHT, INC EXCIMER LASER is the device name listed in this FDA 510(k) record. The listed applicant is Surgilight, Inc.. It received FDA 510(k) clearance on 2000-07-18 under 510(k) number K993328. 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 SURGILIGHT, INC EXCIMER LASER?

SURGILIGHT, INC EXCIMER LASER is a medical device that received FDA 510(k) clearance on 2000-07-18. The listed applicant is Surgilight, Inc.. The 510(k) number is K993328.

When did SURGILIGHT, INC EXCIMER LASER receive FDA 510(k) clearance?

SURGILIGHT, INC EXCIMER LASER received FDA 510(k) clearance on 2000-07-18, under 510(k) number K993328.

Who is the listed applicant for SURGILIGHT, INC EXCIMER LASER?

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 SURGILIGHT, INC EXCIMER LASER?

The FDA product code for SURGILIGHT, INC EXCIMER LASER is GEX. This falls under the Gastroenterology category.

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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.

K020973EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO

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Official Source

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