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FDA 510(k)

PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM

K-Number: K003460 · 2001-01-25

ApplicantPalomar Medical Technologies, Inc.
Decision Date2001-01-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Palomar Medical Technologies, Inc.. It received FDA 510(k) clearance on 2001-01-25 under 510(k) number K003460. 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 PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM?

PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Palomar Medical Technologies, Inc.. The 510(k) number is K003460.

When did PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM receive FDA 510(k) clearance?

PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM received FDA 510(k) clearance on 2001-01-25, under 510(k) number K003460.

Who is the listed applicant for PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM?

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

What is the FDA product code for PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM?

The FDA product code for PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Palomar Medical Technologies, Inc. as applicant

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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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