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FDA 510(k)

PRIMUS AESTHETIC PLATFORM

K-Number: K103664 · 2011-03-17

ApplicantPalomar Medical Technologies, Inc.
Decision Date2011-03-17
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRIMUS AESTHETIC PLATFORM 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 2011-03-17 under 510(k) number K103664. 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 PRIMUS AESTHETIC PLATFORM?

PRIMUS AESTHETIC PLATFORM is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Palomar Medical Technologies, Inc.. The 510(k) number is K103664.

When did PRIMUS AESTHETIC PLATFORM receive FDA 510(k) clearance?

PRIMUS AESTHETIC PLATFORM received FDA 510(k) clearance on 2011-03-17, under 510(k) number K103664.

Who is the listed applicant for PRIMUS AESTHETIC PLATFORM?

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 PRIMUS AESTHETIC PLATFORM?

The FDA product code for PRIMUS AESTHETIC PLATFORM is ONG.

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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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