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FDA 510(k)

LITE TOUCH ERBIUM LASER TREATMENT SYSTEM

K-Number: K974460 · 1998-01-16

ApplicantLorad Corp.
Decision Date1998-01-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LITE TOUCH ERBIUM LASER TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lorad Corp.. It received FDA 510(k) clearance on 1998-01-16 under 510(k) number K974460. 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 LITE TOUCH ERBIUM LASER TREATMENT SYSTEM?

LITE TOUCH ERBIUM LASER TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-16. The listed applicant is Lorad Corp.. The 510(k) number is K974460.

When did LITE TOUCH ERBIUM LASER TREATMENT SYSTEM receive FDA 510(k) clearance?

LITE TOUCH ERBIUM LASER TREATMENT SYSTEM received FDA 510(k) clearance on 1998-01-16, under 510(k) number K974460.

Who is the listed applicant for LITE TOUCH ERBIUM LASER TREATMENT SYSTEM?

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

What is the FDA product code for LITE TOUCH ERBIUM LASER TREATMENT SYSTEM?

The FDA product code for LITE TOUCH ERBIUM LASER TREATMENT SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Lorad Corp. 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)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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