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FDA 510(k)

LOI SYSTEM

K-Number: K090525 · 2009-06-01

ApplicantPalomar Medical Products, Inc.
Decision Date2009-06-01
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LOI SYSTEM 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 2009-06-01 under 510(k) number K090525. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOI SYSTEM?

LOI SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-01. The listed applicant is Palomar Medical Products, Inc.. The 510(k) number is K090525.

When did LOI SYSTEM receive FDA 510(k) clearance?

LOI SYSTEM received FDA 510(k) clearance on 2009-06-01, under 510(k) number K090525.

Who is the listed applicant for LOI SYSTEM?

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 LOI SYSTEM?

The FDA product code for LOI SYSTEM is ONG.

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Other records listing Palomar Medical Products, 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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