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FDA 510(k)

PALOMAR ASPIRE LASER PLATFORM

K-Number: K080567 · 2008-04-16

ApplicantPalomar Medical Products, Inc.
Decision Date2008-04-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR ASPIRE LASER PLATFORM is the device name listed in this FDA 510(k) record. The listed applicant is Palomar Medical Products, Inc.. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K080567. 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 ASPIRE LASER PLATFORM?

PALOMAR ASPIRE LASER PLATFORM is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Palomar Medical Products, Inc.. The 510(k) number is K080567.

When did PALOMAR ASPIRE LASER PLATFORM receive FDA 510(k) clearance?

PALOMAR ASPIRE LASER PLATFORM received FDA 510(k) clearance on 2008-04-16, under 510(k) number K080567.

Who is the listed applicant for PALOMAR ASPIRE LASER PLATFORM?

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

What is the FDA product code for PALOMAR ASPIRE LASER PLATFORM?

The FDA product code for PALOMAR ASPIRE LASER PLATFORM is GEX. This falls under the Gastroenterology category.

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Other records listing Palomar Medical Products, 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.

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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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