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FDA 510(k)

LITETOUCH DENTAL LASER SYSTEM

K-Number: K061966 · 2006-09-27

ApplicantLight Instrument, Ltd.
Decision Date2006-09-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LITETOUCH DENTAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Light Instrument, Ltd.. It received FDA 510(k) clearance on 2006-09-27 under 510(k) number K061966. 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 LITETOUCH DENTAL LASER SYSTEM?

LITETOUCH DENTAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-27. The listed applicant is Light Instrument, Ltd.. The 510(k) number is K061966.

When did LITETOUCH DENTAL LASER SYSTEM receive FDA 510(k) clearance?

LITETOUCH DENTAL LASER SYSTEM received FDA 510(k) clearance on 2006-09-27, under 510(k) number K061966.

Who is the listed applicant for LITETOUCH DENTAL LASER SYSTEM?

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

What is the FDA product code for LITETOUCH DENTAL LASER SYSTEM?

The FDA product code for LITETOUCH DENTAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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