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FDA 510(k)

THERMAGE CPT SYSTEM

K-Number: K132431 · 2013-09-06

ApplicantSolta Medical, Inc.
Decision Date2013-09-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMAGE CPT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical, Inc.. It received FDA 510(k) clearance on 2013-09-06 under 510(k) number K132431. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAGE CPT SYSTEM?

THERMAGE CPT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is Solta Medical, Inc.. The 510(k) number is K132431.

When did THERMAGE CPT SYSTEM receive FDA 510(k) clearance?

THERMAGE CPT SYSTEM received FDA 510(k) clearance on 2013-09-06, under 510(k) number K132431.

Who is the listed applicant for THERMAGE CPT SYSTEM?

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

What is the FDA product code for THERMAGE CPT SYSTEM?

The FDA product code for THERMAGE CPT SYSTEM is GEI.

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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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